FDAFDA · Food and drugs·Recall number Z-0977-2015
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Published January 21, 2015 · Recall initiated: December 19, 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
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- Nationwide Distribution including TX, OH, VA, and Washington, DC.
- Lot
- Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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