Reported Jan 24, 2024 · Ongoing
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM…
Limacorporate S.p.A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele Del Friuli, N/A · N/A
Is this the product you have?
- PRIMA TT Glenoid
- Monoblock/Modular reverse TT baseplatesDescription/Product
- CodeBASEPLATE 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
- Lot codes and dates
- Product Code/UDI-DI
1975.14.500/080333902448241975.14.800/080333902448931975.14.510/080333902312991975.14.810/080333902449091975.14.615/080333902448481975.14.815/080333902449161975.14.865/080333902449301975.14.620/080333902313121975.14.820/080333902449231975.14.870/08033390244947
- Product Code/UDI-DI
- Amount recalled
- 179
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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