FDA Device recall Z-0214-2024
Unity Total Knee System, Model Number 112.001.34
- FDA Device
- Class II
- ongoing
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of Unity Total Knee System, Model Number 112.001.34 by Corin, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0214-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-13 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Corin |
| Distribution | IL, MI, TX |
Product
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Reason
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.
Identifiers
| code_info | UDI/DI 05055343872505, Lot Number 532405. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Corin
- Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
FDA Device · Class II · 2023-11-08 · Corin - Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
FDA Device · Class II · 2022-12-28 · Corin - Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
FDA Device · Class II · 2022-12-28 · Corin - Unity Total Knee System
FDA Device · Class II · 2022-11-30 · Corin - TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800
FDA Device · Class II · 2022-09-07 · Corin
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0214-2024%22
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