Device product
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Z-1753-2024
Product summary
- Firm
- Innomed, Inc.
- Event
- Event 94337
- Status
- Completed
- Classification
- Class II
- Quantity
- 41 devices
- Official record key
device-enforcement:Z-1753-2024
Official wording
Reason: 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
Code information: UDI/DI 00840277104007, Lot Number 1223K
Distribution pattern: FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Derived failure modes
-
Unknown
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.