FDA recall Z-0726-2024

Product

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

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

Key facts

Status

Ongoing

Initiation date

2023-08-29

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Daniele Del Friuli, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2024