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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1317-2023%22
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