Biomet, Inc.: 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

Hazard

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

Details from the source

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 Distribution: Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands. Quantity: 7 units Lot/code info: UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830

UPC codes

05019279515349

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.