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FDAFebruary 21, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

limacorporate s p alimacorporate

UPCs

08033390121798

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 — Recall Details · AllClear