SMR TT Hybrid glenoid Std - Peg S recall
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Why was SMR TT Hybrid glenoid Std - Peg S recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30
- Product
- SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 1
- Distribution
- US: MO
- Recall date
- April 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)