PRIMA TT Glenoid recallZ-0726-2024 · Limacorporate S.p.A · initiated Aug 29, 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
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
FDA root cause category: Device Design
What the company is doing
On 8/29/23, the firm phoned all agents and surgeons to immediately stop surgeries with affected devices. On 10/10/23 the firm emailed recall notices to customers asking them to take the following actions: 1) Surgeons are suggested to perform a short-term patient s monitoring (radiographs at 6 weeks, 3-6 months and 1 year might be considered) and acting accordingly, based on a case-by-case evaluation. 2) Locate, quarantine, and return affected devices. Complete and return the response form to [email protected] 3) Customers with questions can email the firm at [email protected]
Recall details
- Recall number
- Z-0726-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 179
- Product code
- MBF
- FDA submissions
- K222427
- Distribution
- US: IL, MO, CA, IN, MI, OK
Product description
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870
Code information (models, lots, serial numbers)
Product Code/UDI-DI: 1975.14.500/08033390244824, 1975.14.800/08033390244893, 1975.14.510/08033390231299, 1975.14.810/08033390244909, 1975.14.615/08033390244848, 1975.14.815/08033390244916, 1975.14.865/08033390244930, 1975.14.620/08033390231312, 1975.14.820/08033390244923, 1975.14.870/08033390244947
Devices named in this recall
10 devices in the FDA device registry whose identifier appears in the recall's code information.
- PRIMA TT Glenoid 1975.14.500Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration2 recalls0 reports
- PRIMA TT Glenoid 1975.14.800Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration2 recalls0 reports
- PRIMA TT Glenoid 1975.14.615Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall1 report
- PRIMA TT Glenoid 1975.14.510Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.620Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.810Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.815Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.820Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.865Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- PRIMA TT Glenoid 1975.14.870Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
Product lines
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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