FDA-Device2024-05-08Class II

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

Innomed, Inc.
Hazard

54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.

Sold states
FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Affected count
41 devices
Manufactured in
103 Estus Dr, Savannah, GA, United States
Products
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

Official notice

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

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