INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
- Company
- Innomed, Inc.
- Recall Initiated
- March 7, 2024
- Posted
- May 1, 2024
- Recall Number
- Z-1753-2024
- Quantity
- 41 devices
- Firm Location
- Savannah, GA
Reason for Recall
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
Distribution
FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Lot / Code Info
UDI/DI 00840277104007, Lot Number 1223K
Root Cause
Under Investigation by firm
Action Taken
Innomed issued an urgent medical device recall notice to its consignees on 03/07/2024 via email. The notice explained the issue, potential risk to health, and requested the return of the affected devices for US distribution and destruction of the affected devices distributed outside the US.