PRIMA TT Glenoid Monoblock/Modular reverse TT recall
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
Why was PRIMA TT Glenoid Monoblock/Modular reverse TT 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.
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?
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
- Product
- PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 179
- Distribution
- US: IL, MO, CA, IN, MI, OK
- Recall date
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)