Limacorporate S.p.A: 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 FU

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US: IL, MO, CA, IN, MI, OK Quantity: 179 Lot/code info: 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

UPC codes

08033390244824, 08033390244893, 08033390231299, 08033390244909, 08033390244848, 08033390244916, 08033390244930, 08033390231312, 08033390244923, 08033390244947

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.