—#154239

Product

various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060694, K080642, K992119
Affected lot / code info: Items and lots: Item 113870 361800 Item 113951 605610 684300 684310 684320 684330 684340 Item 113952 174480 241520 292440 292480 372590 372600 372610 372620 372630 372640 596930 596940 596950 596960 605640 605650 605670 Item 113954 174560 241500 270220 270230 292490 292510 292520 292560 292570 372650 372660 372670 372680 372700 372710 596970 596980 596990 605680 605690 605700 605710 707650 Item 113956 292580 292590 292640 605720 605730 605740 Item 114827 804070 Item EP-115393 488700 488710 577700 577710 667420 667430 667460 Item EP-115394 488750 577740 Item EP-115395 577760 Item EP-115396 488760 577770 Item EP-115398 832600 Item PM555411 430360 Item XL-115363 169490 179400 488780 488790 488810 488830 488850 488870 488890 488900 488910 488920 515590 560180 560210 667480 667490 667500 667510 744780 744810 773080 Item XL-115364 542280 542290 744850 744870 Item XL-115366 502530 502540 502560 614450 666000 Item XL-115367 630520

Why it was recalled

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2017-02-17
Posted by FDA: 2017-03-27
Terminated: 2018-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.