FDA Medical Device Recalls (openFDA)
Corin Ltd: Unity Total Knee System. Used for knee prosthesis in total knee replacement
- Recall number
- Z-0273-2023
- Recalling firm
- Corin Ltd
- Product
- Unity Total Knee System. Used for knee prosthesis in total knee replacement
- Status
- Terminated
- Initiated
- 2022-10-31
- Posted
- 2022-11-21
- Terminated
- 2024-01-12
- Reason
- The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 4 devices
- Distribution
- Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
- Lot, serial or model codes
- Model Number: 112.040.06; Lot Number: 504337
- 510(k) numbers
- ["K113060"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3002806725
- Firm city
- Cirencester
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28