FDAFDA · Food and drugs·Recall number Z-0954-2013
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
Published March 27, 2013 · Recall initiated: February 7, 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
Increased risk of failure at the driver tip during screw insertion or removal.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ebi, Llc
- Distributor
- Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
- Lot
- Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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