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Recall Observatory FDA recall evidence

Device product

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

Z-1317-2023

February 21, 2023

Class II

Product summary

Firm
Limacorporate S.p.A
Event
Event 91869
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1317-2023

Official wording

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.

Code information: UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30

Distribution pattern: US: MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.