SMR TT Hybrid Glenoid recallZ-1317-2023 · Limacorporate S.p.A · initiated Feb 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Limacorporate S.p.A or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
On 2/21/23, a recall notice was distributed to a customer who was asked to do the following: 1) Check your stock to locate and quarantine the affected devices. Devices must be sent back. 2) Complete, and return the response form to [email protected] 3) The recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Inquiries can be sent to [email protected]
Recall details
- Recall number
- Z-1317-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 21, 2023
- Posted by the FDA
- Apr 1, 2023
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 1
- Product code
- MBF
- FDA submissions
- K163397
- Distribution
- US: MO
Product description
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Code information (models, lots, serial numbers)
UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SMR TT Hybrid Glenoid 1379.59.210Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
Product lines
Other devices under the same FDA submission
9 devices cleared under K163397 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SMR Shoulder GlenosphereLimacorporate SPA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented8 reports
- SMR Shoulder GlenosphereLimacorporate SPA · Shoulder Prosthesis, Reverse Configuration4 reports
- SMR Shoulder GlenosphereLimacorporate SPA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- SMR System 1374.09.111Limacorporate SPA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- SMR System 1376.09.031Limacorporate SPA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- SMR TT Hybrid Glenoid 1379.59.100Limacorporate SPA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- SMR TT Hybrid Glenoid 1379.59.110Limacorporate SPA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 report
- SMR Shoulder 1379.59.110Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 report
- SMR Shoulder 1379.59.330Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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