Data Foundry

Medical device recalls 2023

SMR TT Hybrid glenoid Std — Class II medical device recall Z-1317-2023

Ongoing recall by Limacorporate S.p.A, reported 2023-04-05. Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers,

Recall numberZ-1317-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmLimacorporate S.p.A, San Daniele Del Friuli, N/A, Italy
Recall initiated2023-02-21
Classified2023-03-30
Reported by FDA2023-04-05
Quantity1
UPC / GTIN / UDI-DI08033390121798
Lot numbers08033390121798/2206565
Model numbers1379.59.210

Product

SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1317-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.