Recall Z-2610-2021— Corin Ltd
Class II · Terminated
Class II FDA medical device recall by Corin Ltd, initiated 2021-07-28, terminated 2024-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component 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..
- Recalling firm
- Corin Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-28
- Terminated
- 2024-06-12
- Firm location
- Cirencester, N/A, United Kingdom
Product description
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.