Recall Z-1018-2023— Biomet, Inc.

Name: FDA recall Z-1018-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2022-12-15. It names one FDA 510(k) clearance: K133940. 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. Reason: 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.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-15
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)Biomet UK, Ltd.·cleared 2014-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.