Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
CORIN MEDICAL, LTD. · 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…
Open FDA's page for this record- Cfres ID
- 222992
- Product res number
- Z-0356-2027
- Event date initiated
- 2026-10-02
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 99959
- Product code
- JWH
- Product description
- Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
- Code info
- Part Number: 1232040. UDI-DI/GTIN; 05056139239656. Lot Code: 097921.
- Firm FEI number
- 3002806725
- Recalling firm
- CORIN MEDICAL, LTD.
- Address 1
- Unit 1-57-8 Corinium Centre
- City
- Cirencester
- Country
- United Kingdom
- Additional info contact
- Jon Taylor +44-441285659866
- Root cause description
- Under Investigation by firm
- Product quantity
- 22 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of CA, GA, IL, MI, NC, RI, TX, UT and the countries of Belgium, France, Germany, Hungary.
- 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.
- 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.
- K numbers
- K113060
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3560
- Device class
- 2
- K number
- K131019, K954138, K983835, K894937, K983004, K062274, K930554, K971550, K932776, K220737, K101994, K140555, K244039, K963255, K980925, K230537, K103117, K915132, K873197, K021740, K222380, K925072, K162222, K030686, K203447, K143047, K020383, K032606, K193105, K910992, K180159, K893762, K023788, K202429, K011643, K021451, K090705, K053579, K152169, K012348 +882 more
- Registration number
- 3006563559, 3009923578, 8010379, 3011061242, 3008985661, 3009590742, 3009971621, 3042508254, 3010009693, 3012392319, 3008421730, 3003639920, 1450662, 2528981, 9610612, 2133928, 1000200989, 3004513872, 3005551626, 3030412764, 3027484613, 3010123256, 3002808022, 3015516266, 1000286794, 1825034, 3008868758, 3010163695, 2249697, 3033509898, 1424263, 3007420745, 2245304, 1220477, 3012523063, 3008102042, 3009173317, 3005360851, 3048147961, 1832228 +282 more
- FEI number
- 3002807036, 3006563559, 3009923578, 3011061242, 3008985661, 3009590742, 1000086912, 3009971621, 3042508254, 3010009693, 3012392319, 3008421730, 1000221916, 3003639920, 1450662, 2528981, 3002287318, 1000200989, 3004513872, 3010938185, 3005551626, 3000717902, 3000717687, 3002806534, 3030412764, 3027484613, 3010123256, 3002808022, 3015516266, 1000136269, 1000286794, 3003574398, 1825034, 3008868758, 3010163695, 3033509898, 3007420745, 2245304, 1220477, 3012523063 +282 more