Home / Recalls / Limacorporate S.p.A / Z-2009-2023

Z-2009-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
July 5, 2023
Initiation Date
May 30, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 units

Product Description

REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

Reason for Recall

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

Distribution Pattern

US Nationwide distribution in the states of MI, IL, ND, MO, OK.

Code Information

UDI-DI: 08033390244824; All Lots

Other recalls by Limacorporate S.p.A

  • Z-2025-2025 Class II — PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile (May 19, 2025)
  • Z-2024-2025 Class II — PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, 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-0726-2024 Class II — PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Co (August 29, 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)