FDAFDA · Food and drugs·Recall number Z-0536-2013
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Published December 26, 2012 · Recall initiated: September 29, 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
Broken screw insertor hardness was measured and found to be below the acceptable limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ebi, Llc
- Distributor
- Nationwide Distribution, including the states of MO, TX, and IN.
- Lot
- Lot Numbers 540199, 540199-1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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