FDA Device recall Z-2611-2021
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size…
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size… by Corin, citing the packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2611-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-28 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Corin |
| Distribution | US |
Product
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
Reason
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Identifiers
| code_info | The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 1125182 -…The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 1125182 - Lot number 477942 was delivered 7/22/2021; model 1125243 - Lot number 479310 was delivered 7/23/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Corin
- Unity Total Knee System, Model Number 112.001.34
FDA Device · Class II · 2023-11-08 · 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2611-2021%22
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