Device recall

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

FDA recall source

Recall number

Z-0356-2027

Event id

99959

Status

Open, Classified

FDA classification

Class II

Recalling firm

CORIN MEDICAL, LTD.

Posted

Nov 3, 2026

Initiated

Oct 2, 2026

Product code

JWH

Device type

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Reason

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.

Root cause

Under Investigation by firm

Quantity

22 units

Code info

Part Number: 1232040. UDI-DI/GTIN; 05056139239656. Lot Code: 097921.

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.

Related 510(k)s

K113060

Location

Cirencester, United Kingdom