Recalls / —

—#154313

Product

various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement

FDA product code

HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K971938, K980665

Affected lot / code info

Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150

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 #154313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.