Z-1317-2023 Class II Ongoing
FDA device recall Z-1317-2023 was initiated by Limacorporate S.p.A on February 21, 2023 and is designated Class II. 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 posi… The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- February 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
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 Pattern
US: MO
Code Information
UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30