Class 2 Device Recall various polyethylene implants Custom parts

• Date Initiated by Firm: February 17, 2017
• Date Posted: March 27, 2017
• Recall Status: Terminated on January 29, 2018
• Recall Number: Z-1862-2017
• Recall Event ID: 76507
• Product Classification: unknown device name - Product Code N/A
• Product: various polyethylene implants ; Custom parts; ; Product Usage:; Custom
• Code Information: Items and lots: Item 110010452 732130 920720 Item 110010454 136510 Item 110010455 752320 896040 Item 110010456 383320 879930 Item 110010459 854290 879950 905350 Item 110010462 752460 778490 Item 110010468 827730 Item 110010476 827530 827540 Item 110010716 753050 ItemCP753453 655990 ItemCP753455 656110 ItemCP753461 382210 Item CP753470 436530 Item CP753476 502920 Item CP753478 524950 Item CP753480 436460 Item CP753486 655300 Item CP753488 655470 Item CP753494 467390 Item CP753496 467420 Item CP753502 448730 Item CP753504 453990 Item CP753506 454640 Item CP753508 502970 Item CP753510 831310 Item CP753512 654720 Item CP753514 594570 Item CP753517 594630 Item CP753519 534820 Item CP753521 535090 Item CP753523 654190 Item CP753525 674160 Item CP753531 691490 Item CP753533 691560 Item CP753535 691640 Item CP753537 691680 Item CP753547 691720 Item CP753549 696620
• 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

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.