Recall archive / FDA device enforcement
Unity Total Knee System. Used for knee prosthesis in total knee replacement — FDA record Z-0273-2023
Reported terminated
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 31, 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
- Unity Total Knee System. Used for knee prosthesis in total knee replacement
- Reason
- The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
- Classification
- Class II
- Recalling firm
- Corin Ltd
- Quantity
- 4 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-0273-2023
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 | Model Number: 112.040.06; Lot Number: 504337 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 30, 2022
- Recall initiation date
- Oct 31, 2022
- Center classification date
- Nov 21, 2022
- Termination date
- Jan 12, 2024
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.