INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
FDA Recall #Z-1753-2024 — Class II — March 7, 2024
Product Description
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.
Recalling Firm
Innomed, Inc. — Savannah, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
41 devices
Distribution
FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Code Information
UDI/DI 00840277104007, Lot Number 1223K
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated