FDAFDA · Food and drugs·Recall number Z-1753-2024
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Published May 8, 2024 · Recall initiated: March 7, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Innomed, Inc.
- Distributor
- FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
- Lot
- UDI/DI 00840277104007, Lot Number 1223K
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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