Recall archive / FDA device enforcement
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty — FDA record Z-0213-2024
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 Oct 13, 2023. 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
- Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
- Reason
- Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
- Classification
- Class II
- Recalling firm
- Corin Ltd
- Quantity
- 3 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0213-2024
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/DI: (05055343872499, Lot Number: 529803. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MI, TX, IL
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 8, 2023
- Recall initiation date
- Oct 13, 2023
- Center classification date
- Nov 2, 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.