—#197576

Product

Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341

FDA product code: HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K133940
Affected lot / code info: UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830

Why it was recalled

Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier

Root cause (FDA determination)

Package design/selection

Action the firm took

Zimmer Biomet issued Urgent Medical Device Recall Letter on 12/15/22 to Distributors and Risk Managers/Surgeons. Letter states reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.

Timeline

Recall initiated: 2022-12-15
Posted by FDA: 2023-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197576. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.