FDA Medical Device Recalls (openFDA)
Corin Ltd: Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
- Recall number
- Z-0213-2024
- Recalling firm
- Corin Ltd
- Product
- Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
- Status
- Open, Classified
- Initiated
- 2023-10-13
- Posted
- 2023-11-02
- Terminated
- not on file
- Reason
- Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
- Root cause
- Process change control
- Action
- Corin issued a FIELD SAFETY NOTICE/RECALL LETTER to its consignees on 10/13/2023 via email. The notice explained the problem, potential risk if used, and requested the return of unused units. Distributors were directed to communicate the notice to applicable hospitals.
- Quantity
- 3 units
- Distribution
- US: MI, TX, IL
- Lot, serial or model codes
- UDI/DI: (05055343872499, Lot Number: 529803.
- 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