[Recalled] 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
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Corin Ltd |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2611-2021 |
| Country of notice | United Kingdom |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 28 July 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Corin Ltd
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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