Device product
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Z-1317-2023
Product summary
- 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
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.