FDAFDA · Food and drugs·Recall number Z-0624-2014
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Published January 15, 2014 · Recall initiated: September 11, 2013
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
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- US Distribution: including states of: TX and VA.
- Lot
- Lot: 012212-001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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