Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee jo...
FDA Recall #Z-1018-2023 — Class II — December 15, 2022
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
Recalling Firm
Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
Code Information
UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated