Recall Z-1753-2024— Innomed, Inc.
Class II · Completed
Class II FDA medical device recall by Innomed, Inc., initiated 2024-03-07. FDA's recall record names no specific 510(k) clearance for this event. Product: INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup. Reason: 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.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2024-03-07
- Firm location
- Savannah, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.