FDAFDA · Food and drugs·Recall number Z-0866-2014
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
Published February 5, 2014 · Recall initiated: January 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Distributor
- US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
- Lot
- TI13J01811
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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