Corin Unity Knee ASC modular handle recalled for locking failure risk
Corin Medical is recalling 22 Unity Knee ASC Modular Handles, part number 1232040, which are included in the Corin Unity ASC Instrument System. The locking mechanism may fail, so instruments already attached may not disengage and the handle may not fit securely onto unattached instruments. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Set aside Unity Knee ASC modular handles, part number 1232040, lot 097921 (UDI-DI 05056139239656), and do not use them.
- Contact Corin Medical, Ltd. for instructions, because the notice does not specify a remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 22 units
- Illnesses reported
- None reported
- Manufactured in
- Unit 1-57-8, Corinium Centre, Cirencester, United Kingdom
- Classification
- Class II
- Recall number
- Z-0356-2027
In the FDA's words
- Description
- Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040. 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. 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. Affected quantity: 22 units
- Hazard
- 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.