Recall archive / FDA device enforcement
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) — FDA record Z-1261-2023
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 Jan 25, 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
- TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
- Reason
- Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
- Classification
- Class II
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 5 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1261-2023
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 | Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Distribution to: TX
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
- Mar 22, 2023
- Recall initiation date
- Jan 25, 2023
- Center classification date
- Mar 16, 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.