Recall archive / FDA device enforcement
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in con... — FDA record Z-1018-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Biomet, Inc.
- Quantity
- 7 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1018-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 1, 2023
- Recall initiation date
- Dec 15, 2022
- Center classification date
- Jan 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.