Depuy bone cement recall DePuy Ireland is initiating a medical device recall (removal) of one lot of the ATTUNE™ Cementless CR Femurs listed in the above table. Simplex HV bone cement is a variety of high viscosity bone cement. GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. I ask the doctor office staff to request a copy Product complaint # (b)(4). Manufacturer Depuy Orthopaedics, Inc. Total knee replacements (TKR) surgeries are done at the astonishingly high rate of 600,000 per year in the U. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. Bone cement includes a liquid as well as the powder that have to be combined. 8M; By Stacy Lawrence Mar 6, 2015 11:53am. knee January 2017, same knee manufacturer. DePuy’s Attune knee has never been recalled, but people filed lawsuits over the implants claiming tibial loosening. The implant had the potential Bone cement products that have been linked to failure are: DePuy CMW 1 Bone Cement, DePuy SmartSet HV Bone Cement, Stryker/Howmedia Simplex HV Bone Cement, and Biomet/DJO Surgical Cobalt HV Bone Cement. High viscosity means that the cement is thicker than a medium or low viscosity cement. 5%, 1% and 1. . 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 DEPUY ORTHOPAEDICS, INC. Arthrex recalled about 2,400 units of its iBalance TKA Tibial Tray in December 2015. They come in a variety of sizes Catalog NOs. D10 concomitant products: JOHNSON & JOHNSON/ JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. Has a recall been issued for your specific knee implant? Knee replacement devices have been recalled for a variety of The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). 2. This report is being submitted pursuant to the provisions of 21 cfr, part 803. Aseptic loosening is when the device moves out of place without Product complaint # (b)(4). One such brand is DePuy, a subsidiary of the Johnson & Simplex HV bone cement is a surgical product made by Stryker, and was approved by the FDA through the expedited 510(k) approval process. In a clinical setting, cemented hip stems are fixed in position with bone cement with approximate density and Young's modulus of 1. The notification described the product, problem and actions to be taken. The product in question is used to attach and secure a joint Bone cement, Osa explains, is used to attach the components of the artificial knee joint to the femur and the tibia. DePuy is a subsidiary of pharmaceutical giant, Johnson & Johnson. Type of Device: BONE CEMENT : BONE CEMENT. The failure of this adhesion process is the primary issue behind the alarming failure rate of the DePuy Attune system. knee replacement, Depuy Sigma cement, March 2016. However, based on the complaint what most likely happened was that the surgeon connected the cap to the reservoir before transferring cement, which would cause the plunger to be in the empty cement reservoir. This can lead to oxygen deficiency, embolism, heart attacks and in some cases, death. 2 The PALACOS ® product portfolio at a glance: Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2103-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. They include: DePuy CMW 1 Bone Cement; Stryker/Howmedia Simplex HV Bone Cement; DePuy SmartSet HV Bone Cement; Biomet/DJO Surgical Cobalt HV Bone Cement; How to Recover Compensation for Bone Cement: Mass Tort Brands Associated with Bone Cement Failure. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a In order to adhere the implant to the patient’s natural bone, a special type of adhesive cement is employed. High viscosity bone cement specifically is the type at issue. The It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. Doctors use the instruments to implant Product Description : Antibiotic Simplex Bone Cement with Erythromycin/Colistin is packaged in two sterile components. Product Information: SmartSet HV Bone Cement, 40G, High-Viscosity Manufacturer Part # 3092-040 Description Developed to meet the needs of today's orthopedic surgeons DePuy bone cement recalled; InspireMD raising $13. The knee implant lawsuit says The patient was revised to address loosening of the femoral component at the bone to cement interface. 1 Event Recall of Device Recall DePuy CEMENT RESTRICTOR, Size 5 Device Recall DePuy CEMENT RESTRICTOR, Size 5. Type of Device: CEMENT. Circular Staplers. to address the challenges of reduction and fixation as well as the importance of early mobilization in compromised bone. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 3: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Size 3, Sterile, DePuy Orthopaedics. Code Information A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e. This device is intended to restrict bone cement migration into the distal Recall of DePuy CMW 2 Gentamicin Bone Cement 20 g According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced Many patients who have had knee replacement surgery using DePuy CMW 1 bone cement are having to undergo revision surgery due to product failure. 1818910 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 545032500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Search Alerts/Recalls : New Search DEPUY BONE CEMENT: Back to Search Results: Model Number 3102-040: Device Problem Insufficient Information (3190) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: BONE CEMENT. Porous coated implants may be used with or without cement. 2 (Liquids, SmartSet) Date: 8 May 2014 Supersedes: May 2011 Page 4 of 9 6. DePuy Synthes has had a history of making faulty, malfunctioning knee replacement device glue. At least four product liability lawsuits have been filed in the wake of Johnson & Johnson’s DePuy ASR hip recall that was announced last week. This item may require 1-2 days to ship out from our facility. the intended use stated in the ifu for the smartset¿ gmv endurance gentamicin bone cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive Bone Cement: 510(k) Number: K033563: Device Name: SMARTSET GHV GENTAMICIN BONE CEMENT: Applicant: DEPUY ORTHOPAEDICS, INC. The system consists of five parts: o Femoral Head DePuy Knee Replacement Lawsuits. Model / Serial Product Code 546018000, Lot sET5EV4 and DePuy Synthes is a franchise of orthopaedic and neurosurgery companies acquired by Johnson & Johnson in 1998. 5%) w/w of MgO and TiO 2 were The confidence 11cc spinal cement system was not returned for evaluation. Medical Device Product Recall (Removal) – Ref. No Attune knee implants have ever been recalled. BONE CEMENT: Back to Search Results: Device Problem Loosening of Implant Not Related to Bone-Ingrowth cases such as mine with a total knee replacement. Investigation summary : no device associated with this report was received for examination. They said the cement failed to bond the implant’s base plate to the patient’s tibia, which is one of the bones in the lower leg. 1 Overview of Recall Database 7. Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 2 20G. , a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities and trauma, as well as bone cement and operating room products. WARSAW, IN 46581-0988: PMA Number Several brands manufacture bone cement, and some have unfortunately been associated with bone cement complications. DePuy CMW 2 is designed for digital application to small joints such as the knee patella and the hip SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. 700 ORTHOPAEDIC DRIVE: WARSAW, IN 46581 -0988 Applicant Contact: TIFFANI D ROGERS: Recalls: CDRH Recalls - - Links on this page: Page Last Updated: 12/23/2024. This would prevent the reservoir from being loaded correctly and a new set would Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2102-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. MedTech @FierceMedDev: Navidea joins forces with Bone Cement (4) Cages and Spacers (11) Cartilage Restoration. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. The FDA began investigating DePuy CMW 1 bone cement after receiving an Adverse Event Report in September 2012. Depuy synthes considers the investigation closed. 040S TRAUMACEM V+ Bone Cement, injectable Description TRAUMACEM V+ Injectable Bone Cement consists of sterile packed compo - nents to create radiopaque TRAUMACEM V+ Injectable Bone Cement. 5 minutes at 19°C 4. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis. Its companies form part of the Johnson & Johnson Medical Devices Group. These high viscosity bone cements, from a number of manufacturers, are being targeted in this investigation: Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement (NOT CMW 2 or CMW 3) Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) DePuy Orthopaedics, Inc. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis Manufacturer Depuy Orthopaedics, Inc. Device history lot : no lot information available. 3027: Applicant: DEPUY, INC. Cement-less knees: in traditional knee surgery, cement is used to bond the knee implants with the existing bones. DePuy Orthopaedics, Inc. Bone cement implantation syndrome, or BCIS, is a severe complication of knee replacement surgery. The ATTUNE™ Cementless Total Knee System is intended for cementless use within the ATTUNE™ Total Knee Replacement System. Between 2003 and 2013, DePuy issued at least 200 knee replacement-related recalls. 700 ORTHOPAEDIC DR. Had revision on rt. No complications were noted. Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in Class 2 Device Recall Cobalt HV Bone Cement with Gentamicin: Date Initiated by Firm: June 26, 2017: Date Posted: November 06, 2017: Recall Status 1: Open 3, Classified: Recall Number: Z-0067-2018: Recall Event ID: 77801: 510(K)Number: K051496 : Product Classification: Bone cement - Product Code LOD: Product: Cobalt HV with Gentamicin, Cobalt Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement; Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Bone cement failure typically occurs for one of two reasons: either aseptic loosening or bone cement implantation syndrome. You can find instructions on how to use this product included with the product packaging. DePuy Synthes recalled 277 knee implant devices and parts between 2002 and 2013. In June 2015, DePuy issued a Class II recall for approximately 3,274 units of the Attune® knee replacement because a small wire spring could potentially break off during The smartset¿ gmv endurance gentamicin bone cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the us fda. alone. We examined – The use of Vertecem V+ Cement Kit bone cement during pregnancy or lactation is not recommended. Model / Serial Product Code 546010000, Lot ET5DV4, Size 1. The long clinical heritage of our DePuy CMW™ bone cement product range has allowed us to evaluate and refine the product range over time. Device Recall DePuy Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. Notifications were sent to consignees with the DePuy SmartSet Bone Cement – Liquid Component Version 2. There are many brands that manufacture bone cement that has unfortunately been linked to failure or sometimes BCIS. DePuy Knee Implant Recall. DePuy Orthopaedics, Inc. The FDA’s database shows at least six other DePuy knee replacement recalls since 2013. , Johnson & Johnson, Stryker Corporation, Howmedica Osteonics Corporation, and AAP Implants Inc. The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon The amount of time depends on whether the implant was cemented to the bone in the first place, or whether it gradually loosened over time. But to date, there have been no recalls of Attune Knee implants. SMARTSET Bone Cements are the latest cements in the DePuy Synthes portfolio. KG (Mfg Site) LINK SymphoKnee System Distal Femoral Augment: Arthroplasty: 7/3 Loosening of the device due to cement failure; Bone fractures; Unexpected wear and tear; Early device failure; Revision surgery; In 2017, DePuy was forced to recall part of the Sigma device line. Events. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. In other cases, the toxic ingredients contained in DePuy CMW 1 bone cement leech into the patient’s tissues and blood vessels. 92496: Waldemar Link GmbH & Co. The Sigma HP PFJ cemented trochlear implant which is attached to the femur to provide the patellar groove needed for knee movement was found to be This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis. Additionally, between 2002 and 2013, DePuy Synthes recalled 277 knee implant devices and components, and in 2015 DEPUY CMW 9619821 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3312-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 1 40G. It is intended for treatment of osteoporotic fractures of the upper and lower extremities in combination with DePuy Synthes fixation devices intended for The defendants include Depuy Synthes Sales Inc. For example, in 2015, the company was forced to recall its SMARTSET GVH Gentamicin Bone Cement via an FDA Class II medical device recall. An article in Device Classification Name: Bone Cement, Antibiotic: 510(k) Number: K061144: Device Name: DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT: Applicant Acrylic bone cement is the most common method of fixation for primary total knee arthroplasty (TKA). One component is an ampoule containing 10ml, or 20ml of a colourless, flammable liquid monomer that has a sweet slightly acrid odour and contains Methyl methacrylate (monomer), N,N-dimethyl pare toluidine and Hydroquinone. Had rt. The resin was consequently left for 24 h to solidify completely. 3 Methods and materials for containment and clearing up Clean up small spills of less than20 ml through use of absorbent material and dispose of contaminated material Device Recall DePuy CEMENT RESTRICTOR , Size 1. Cement, bone, vertebroplasty - Product Code NDN: Product: The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. The cases, which allege that the metal-on-metal hip For more than 60 years PALACOS ® has been successfully used in arthroplasty for effective and permanent fixation of implants in bone. Its proven clinical use has been demonstrated by more than 40 million procedures worldwide. It was recalled. In cement-less knees, the bone naturally fuses with the implant. S. 702. In considering use of Vertecem V+ Cement Kit bone cement in a pregnant patient, the responsible physician should weigh the benefits of the application of Vertecem V+ Cement Kit bone cement against the potential risks to the patient and the pregnancy. Smartset GMV gentacimin bone cement. DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-35-500: including depuy patella were utilized along with depuy cement x2. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This report may be based on information which has not been investigated or verified prior to the required reporting date. 16, 2015. The DePuy bone cement is used to adhere parts of an artificial knee joint into the femur (upper leg bone) and tibia (the major bone of the lower leg). 700 Orthopaedic Dr Warsaw IN 46582-3994: For Additional Information Contact: DePuy Synthes Sales Consultant. 2 Recall Results: Cemented Total First MTP Joint Implants ( k) pathway with bone cement as the method of fixation. Manufacturer (Section D) DEPUY: MDR Report Key: 4603943: Related to previous work of enhanced bone cement properties by using MgO and TiO 2 , samples of composite bone cement using three different ratios (0. They come in a variety of sizes The problem may stem from cement failing to bond components to the prosthesis. DePuy Recalls Before 2015. It is intended for use in patients with instability in soft tissues or with deficiencies or damage in the surrounding bone. Manufacturer (Section D) Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1. 1 Among all bone cements, PALACOS ® is the leader in the number of published studies. , hip replacement, arthroplasty, or vertebroplasty). DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW. Several studies have described good short-term outcomes; however, there have been reports of early failures due to tibial baseplate debonding at the implant-cement interface of The ATTUNE Knee System (DePuy Synthes, West Chester, PA). Frank was subject to the use of Stryker bone cement known as Simplex HV bone cement—the HV standing for high viscosity—on Nov. Alleged Dangers of Simplex Bone Cement. Size 4, Sterile, DePuy Orthopaedics. Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical Unfortunately we can’t detect an electronic copy of the Instructions for Use (IFU) you are seeking. Bone cement: A mixture formed by the chemical reaction of two chemical agents (a monomer and a polymer) that produces a grout-like material that is used for some joint The DePuy Ceramax® Ceramic Total Hip System is a ceramic-on-ceramic bearing total hip replacement prosthesis system. (sticker sheet page 276 of 570). g. DePuy developed and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands. The surgeon removes damaged bone and replaces it with the Attune knee prosthesis. Among the brands named in lawsuits are Arthrex’s iBalance total knee arthroplasty system and DePuy’s Attune knee system. The company has also recorded the most Class I recalls, which are reserved for those products reasonably likely to cause serious injury or death. I need a lawyer Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY IRELAND - 3015516266 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3312040: Device Problem Adverse Event Without Identified Device or Use Problem (2993 Class 2 Device Recall DePuy: Date Initiated by Firm: June 29, 2022: Create Date: July 20, 2022: Recall Status 1: Open 3, Classified: Product: ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525: Code Information: GTIN: 10603295434061 07. 2293230 Product Subject to this Removal: Part Number Part Description Lot GTIN 1504-01-204 ATTUNE CR Femoral Right Size 4 Porous 3883327 10603295041474 Dear Surgeon, By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the DePuy also recalled almost 14,000 Attune knee surgical tools in 2015. Depuy cement was used. I discovered that there were knee replacements that had been on recall, etc. Field Safety Notices about DePuy CMW2 Gentamicin Bone Cement According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was In fact, from 2003 to 2013, DePuy had the most knee system and component recalls of any knee implant maker, with almost 280. The plaintiff says he was was TRAUMACEM™ V+ System is a polymethylmethacrylate cement for augmentation of a trauma device that allows injection of a controlled amount of cement into a femoral head. 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 3 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3332-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Doi: (b)(6) 2016, dor: (b)(6) 2020, left knee. In some cases, the cement can break down, causing devise failure. But in June 2015, DePuy recalled its Attune Knee Tibial Articulation Surface Instruments. Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. A recent lawsuit from 2018 alleged DuPuy’s SmartSet cement caused the The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's DePuy Synthes offers an innovative spine portfolio that includes products designed to address the most complex and challenging cases in spine Bone Cement (3) Cages and Spacers (10) Instruments (2) Personalization and 2 DePuy Synthes SMARTSET ™ Bone Cements Product Information INTRODUCTION Our experience in PMMA bone cements is extensive. 4,5 ARTICUL/EZE™ Ceramic Heads offer Permallon® Avant ceramic in an expanded size range over the current DePuy Synthes ceramic head Recall Event ID: 57900: 510(K)Number: K800894 : Product Classification: Prosthesis, hip, cement, restrictor - Product Code JDK: Product: DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy Orthopaedics. Learn more about By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the ATTUNETM Cementless CR Femurs listed in the above table. , Depuy Orthopaedics Inc. Called the Sigma HP PFJ cemented trochlear implant, this component was implicated in the high number of revisions in patients who had received the knee system. Some of the most recent knee implant products recalled by DePuy include: Product complaint # (b)(4). Four Depuy total knee replacement recalls were classified as Class I, implying a reasonable probability that consuming the product might result in serious adverse health effects or death. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET GHV Gentamicin Bone Cement DePuy CMW™ 2 Bone Cement is our fast-setting high viscosity bone cement, setting in approximately 6. None recalled “intolerance” reactions to topical drugs (including Orthopaedic bone cement restrictor instrumentation. || SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, Recall Status 1: Terminated 3: Recall Number: Z-0064-2014: Recall Event ID: 66248: Medium Viscosity Antibiotic Bone Cement, Sterile. 574-267-8143: Manufacturer Reason for Recall: The subject product lots are being recalled because they received a higher than specified irradiation dose. Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Any DePuy SmartSeal pressurisers that have a black tick on the bottom right hand corner of the pouch and on the carton have already been re 7. The role of antibiotic-loaded bone cement in complicated knee arthroplasty: relevance of gentamicin allergy and benefit from revision surgery — a case control follow-up study and algorithmic approach Furthermore, 6 patients reported a family history of atopic diathesis. On (b)(6) 2018, the patient had an arthroscopic debridement of total right knee Device: DEPUY 1 BONE CEMENT: Generic Name: BONE CEMENT: Regulation Number: 888. all lot numbers are affected by this recall. K863528 DEPUY BICONDYLAR TOE PROSTHESIS Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. barwcph hhwze vtekd arj jhpwdo euwm zyy avr xtcnwdh zfvk