Recall archive / FDA device enforcement
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 — FDA record Z-0899-2022
Reported completed
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 Feb 22, 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
- iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
- Reason
- Incorrect tibial base plate implant packaged in kit
- Classification
- Class II
- Recalling firm
- Conformis, Inc.
- Quantity
- 1 unit
- Agency-reported status
- Completed
- Source record identifier
- Z-0899-2022
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 | Serial Number: 0496242 UDI: M572TPS3011113011 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MS
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
- Apr 20, 2022
- Recall initiation date
- Feb 22, 2022
- Center classification date
- Apr 8, 2022
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.