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FDA (Device enforcement)Recalled 2023-02-21class ii

Limacorporate S.p.A: SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

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.

Details from the source

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. Distribution: US: MO Quantity: 1 Lot/code info: UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30

UPC codes

08033390121798

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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