Recall archive / FDA device enforcement
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 — FDA record Z-1317-2023
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 Feb 21, 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
- SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
- Reason
- Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
- Classification
- Class II
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 1
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1317-2023
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 | UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MO
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 5, 2023
- Recall initiation date
- Feb 21, 2023
- Center classification date
- Mar 30, 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.