Recall Z-1753-2024 ยท HWB Extractor
Innomed, Inc.
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
| Date | May 1, 2024 (initiated Mar 7, 2024) |
| Status | Completed |
| Reason | 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 41 devices |
| Distribution | FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.