FDA Device recall Z-1317-2023
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 by Limacorporate S P A, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1317-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-21 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Limacorporate S P A |
| Distribution | MO |
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.
Identifiers
| code_info | UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Limacorporate S P A
- PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis
FDA Device · Class II · 2025-01-01 · Limacorporate S P A - PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
FDA Device · Class II · 2024-01-24 · Limacorporate S P A - PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
FDA Device · Class II · 2023-12-20 · Limacorporate S P A
All Limacorporate S P A recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1317-2023%22
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