FDA recall Z-1753-2024

Innomed, Inc. · Class II · device

Product

INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

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

Key facts

Status
Completed
Initiation date
2024-03-07
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Savannah, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1753-2024