FDAFDA · Food and drugs·Recall number Z-1811-2014
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Published June 25, 2014 · Recall initiated: May 15, 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
The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ebi, Llc
- Distributor
- Worldwide Distribution - USA (nationwide) and the country The Netherlands.
- Lot
- Catalog Number 14-501669; Lot Number 006731
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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