Z-0356-2027

Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040

Name: Z-0356-2027 Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040
Creator: Corin Medical, Ltd.
Published: 2026-10-02
License: https://open.fda.gov/license/

Corin Medical, Ltd. / initiated 2026-10-02 / Open, Classified

FDA source

Recall record

Recall number: Z-0356-2027
Status: Open, Classified
Initiated: 2026-10-02
Posted: 2026-11-03
Recalling firm: Corin Medical, Ltd.
Product: Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will not be able to be disengaged, and the handle will be unable to fitted securely to any unengaged mating instruments.
FDA root cause: Under Investigation by firm
Action: Corin notified consignees on about 10/02/2026 via emailed "URGENT MEDICAL DEVICE REMOVAL" letter. Consignees were instructed to identify the products present in inventory and quarantine them, return the devices to Corin (replacement parts will be provided), provide the notification letter to all involved parties, and complete and return the acknowledgement form. Additionally, Corin requested notification if affected units have been further distributed as well as any affected customers so that they may be notified.
Quantity in commerce: 22 units
Distribution: Worldwide - US Nationwide distribution in the states of CA, GA, IL, MI, NC, RI, TX, UT and the countries of Belgium, France, Germany, Hungary.
Product codes and lots: Part Number: 1232040. UDI-DI/GTIN; 05056139239656. Lot Code: 097921.

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-06. View this recall on fda.gov (opens on fda.gov)