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U.S. Department of Health and Human Services

Class 2 Device Recall Unity Knee ASC Modular Handle

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 Class 2 Device Recall Unity Knee ASC Modular Handlesee related information
Date Initiated by FirmOctober 02, 2026
Date PostedNovember 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0356-2027
Recall Event ID 99959
510(K)NumberK113060 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductUnity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
Code Information Part Number: 1232040. UDI-DI/GTIN; 05056139239656. Lot Code: 097921.
FEI Number 3002806725
Recalling Firm/
Manufacturer		 CORIN MEDICAL, LTD.
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information ContactJon Taylor
+44-441285659866
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionCorin 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 Commerce22 units
DistributionWorldwide - US Nationwide distribution in the states of CA, GA, IL, MI, NC, RI, TX, UT and the countries of Belgium, France, Germany, Hungary.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
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