FDA Recall
Completed
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Recall: Z-1753-2024
·
Initiated March 7, 2024
Recall
- Recall Number
- Z-1753-2024
- Event Number
- 94337
- Firm
- Innomed, Inc.
- FEI Number
- 1833053
- Product Code
- HWB
- Status
- Completed
- Root Cause
- Under Investigation by firm
- Initiated
- March 7, 2024
- Posted
- May 1, 2024
- Address
- 103 Estus Dr, Savannah, GA, 31404-1445
Description
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Reason
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
Action
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.
Distribution
FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Quantity
41 devices