Z-0273-2023Class II

Unity Total Knee System. Used for knee prosthesis in total knee replacement

Name: Z-0273-2023 Unity Total Knee System. Used for knee prosthesis in total knee replacement
Creator: Corin Ltd
Published: 2022-10-31
License: https://open.fda.gov/license/

Corin Limited / initiated 2022-10-31 / Terminated / root cause: packaging

FDA source

Corin Ltd began a recall of Unity Total Knee System. Used for knee prosthesis in total knee replacement on 2022-10-31. FDA classified it as Class II and gives the reason as "The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0273-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-31
Posted: 2022-11-21
Terminated: 2024-01-12
Recalling firm: Corin Limited
Product: Unity Total Knee System. Used for knee prosthesis in total knee replacement
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: packaging
FDA 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 [email protected]. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to [email protected].
Quantity in commerce: 4 devices
Distribution: Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Product codes and lots: Model Number: 112.040.06; Lot Number: 504337

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0273-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0273-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-21

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)