Unity Total Knee System. Used for knee prosthesis in total knee replacement
FDA device recall Z-0273-2023 · posted 2022-11-21 · Terminated
Recall details
- Recalling firm
- Corin Ltd
- Reason for recall
- The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
- Action taken
- Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to vigilance@coringroup.com. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to vigilance@coringroup.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 4 devices
- Distribution
- Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
- Date initiated
- 2022-10-31
- Date posted
- 2022-11-21
- Date terminated
- 2024-01-12
- Location
- Cirencester, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNITY TOATAL KNEE SYSTEM (K113060) | Corin USA | 2012-09-10 |