Home / Recalls / Limacorporate S.p.A / Z-0726-2024

Z-0726-2024 Class II Ongoing

Recalled by Limacorporate S.p.A — San Daniele Del Friuli, N/A

Recall Details

Product Type
Devices
Report Date
January 24, 2024
Initiation Date
August 29, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
179

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

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 Pattern

US: IL, MO, CA, IN, MI, OK

Code Information

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

Other recalls by Limacorporate S.p.A

  • Z-2024-2025 Class II — PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile (May 19, 2025)
  • Z-2025-2025 Class II — PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile (May 19, 2025)
  • Z-0744-2025 Class II — TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.0 (October 2, 2024)
  • Z-0524-2024 Class II — PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 (October 27, 2023)
  • Z-2009-2023 Class II — REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R (May 30, 2023)
  • Z-2010-2023 Class II — REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R (May 30, 2023)
  • Z-1317-2023 Class II — SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 (February 21, 2023)
  • Z-1261-2023 Class II — TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of (January 25, 2023)
  • Z-0160-2022 Class II — REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5 (October 1, 2021)
  • Z-0159-2022 Class II — REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5 (October 1, 2021)