Recall archive / FDA device enforcement
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 — FDA record Z-0524-2024
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 27, 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
- PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
- Reason
- Due to incorrect product labeling
- Classification
- Class II
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 33 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0524-2024
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 | Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S Distribution: AZ, CA, IL, LA, and NY
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
- Dec 20, 2023
- Recall initiation date
- Oct 27, 2023
- Center classification date
- Dec 9, 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.