Reported Apr 5, 2023 · Ongoing
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Limacorporate S.p.A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele Del Friuli, N/A · N/A
Is this the product you have?
- SMR TT Hybrid glenoid Std - Peg S
- REF1379.59.210
- Lot codes and dates
- UDI-DI/Lot/Expiration08033390121798/2206565/2027-04-30
- Amount recalled
- 1
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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