Home / Recalls / Corin Ltd / Z-0214-2024

Z-0214-2024 Class II Ongoing

Recalled by Corin Ltd — Cirencester, N/A

Recall Details

Product Type
Devices
Report Date
November 8, 2023
Initiation Date
October 13, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 units

Product Description

Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

Reason for Recall

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Distribution Pattern

US: MI, TX, IL

Code Information

UDI/DI 05055343872505, Lot Number 532405.

Other recalls by Corin Ltd

  • Z-0213-2024 Class II — Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision (October 13, 2023)
  • Z-0726-2023 Class II — Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 (November 8, 2022)
  • Z-0727-2023 Class II — Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 (November 8, 2022)
  • Z-0273-2023 Class II — Unity Total Knee System. Used for knee prosthesis in total knee replacement (October 31, 2022)
  • Z-1509-2022 Class II — Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENT (July 22, 2022)
  • Z-1667-2022 Class II — TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemen (July 12, 2022)
  • Z-2604-2021 Class II — Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321. (July 28, 2021)
  • Z-2612-2021 Class II — Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.01 (July 28, 2021)
  • Z-2603-2021 Class II — Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. (July 28, 2021)
  • Z-2606-2021 Class II — Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322. (July 28, 2021)