Device 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
Z-1018-2023
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 91365
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1018-2023
Official wording
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
Code information: UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
Derived failure modes
-
Unknown
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