Class 2 Device Recall various polyethylene implants

• Date Initiated by Firm: February 17, 2017
• Date Posted: March 27, 2017
• Recall Status: Terminated on January 29, 2018
• Recall Number: Z-1861-2017
• Recall Event ID: 76507
• 510(K)Number: K040770 K042757 K060525
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: various polyethylene implants ; Knees; Revision Tibial Tray Systems; Oxford Partial Knee; Orthopedic Salvage System; Vanguard Complete Knee System; Vanguard SSK Revision System; Biomet Patella; Maxim Complete Knee System; Biomet Series A Patella ; Vanguard 360 Revision System; Vanguard Deep Dish Rotating Platform; Biomet CP Bearings; ; Product Usage:; For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
• Code Information: Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 466430 516220 516230 516240 584590 609910 Item 141265 466440 527490 609920 684740 Item 141266 584620 Item 141268 527590 Item 141481 412820 920390 Item 141482 289810 412870 805950 920410 Item 141483 537790 Item 141484 412920 903910 Item 141485 920420 Item 141512 781920 781960 805970 Item 141514 806010 Item 141515 827960 Item 150410 241990 373830 596750 Item 150411 231200 373840 373850 Item 150412 129940 231210 231220 596910 Item 150413 129950 Item 150414 409730 Item150415 129960 596920 Item 150476 510910 510930 510940 Item 150477 780710 780720 780730 780750 780760 Item 150478 240650 576750 576760 576770 576780 Item 159540 347930 373920 373940 456340 456350 545520 545530 Item 159541 341160 347940 347950 456370 456380 Item 159542 373970 442290 528600 Item 159543 293050 444990 Item 159544 347970 Item 159547 374010 456390 545540 661660 Item 159548 374020 374030 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• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Customer Service; 800-348-2759
• Manufacturer Reason for Recall: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
• FDA Determined Cause: Process design
• Action: On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Clearly mark RECALL on the outside of return boxes. 5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
• Quantity in Commerce: 28,253 in total
• Distribution: Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH and Original Applicant = BIOMET MANUFACTURING CORP.; 510(K)s with Product Code = JWH and Original Applicant = BIOMET MANUFACTURING, INC.; 510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.