FDA recall, , Moderate risk
Corin Unity Knee ASC Modular Handle
The Unity Knee ASC Modular Handle may malfunction, causing its locking mechanism to fail.
Summary by Recall Canary from the FDA notice
What happened
CORIN MEDICAL, LTD. of Cirencester, United Kingdom, is voluntarily recalling the Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. The recall was initiated on October 2, 2026, and added to the FDA's Enforcement Report on November 3, 2026.
The potential malfunction of the Modular Handles is where the locking mechanism may fail, and 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.
The recall affects 22 units distributed worldwide, including in the U.S. states of California, Georgia, Illinois, Michigan, North Carolina, Rhode Island, Texas, and Utah, and the countries of Belgium, France, Germany, and Hungary.
Customers were notified by letter. The recall was classified by the FDA on November 3, 2026.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the lot code and part code listed under your product.
Unity Knee ASC Modular Handle included in the Corin Unity ASC Instrument System
- Part code
- 1232040.
- Lot code
- 097921
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
Worldwide - US Nationwide distribution in the states of California, Georgia, Illinois, Michigan, North Carolina, Rhode Island, Texas, Utah and the countries of Belgium, France, Germany, Hungary.
- Recalled by
- CORIN MEDICAL, LTD.Cirencester, United Kingdom
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99959
- Recall number
- Z-0356-2027
- Quantity recalled
- 22 units
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from CORIN MEDICAL, LTD.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
CORIN MEDICAL began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
