FDAFDA · Food and drugs·Recall number Z-1957-2013
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Published August 21, 2013 · Recall initiated: May 9, 2012
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 nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- Distributed in DC and the states of MA, and OK.
- Lot
- Lot Number: 011836-0001, 011981-001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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