Z-0214-2024Class II

Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

Name: Z-0214-2024 Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Creator: Corin Ltd
Published: 2023-10-13
License: https://open.fda.gov/license/

Corin Limited / initiated 2023-10-13 / Open, Classified / root cause: labeling and UDI

FDA source

Corin Ltd began a recall of Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty on 2023-10-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0214-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-13
Posted: 2023-11-02
Recalling firm: Corin Limited
Product: Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 1 units
Distribution: US: MI, TX, IL
Product codes and lots: UDI/DI 05055343872505, Lot Number 532405.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0214-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0213-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-02
Z-0214-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-02

Product code JWH

K113060Class IIUnity Toatal Knee SystemCorin USA / cleared 2012-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)