FDAFDA · Food and drugs·Recall number Z-1441-2017
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Published March 22, 2017 · Recall initiated: January 23, 2017
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
Incorrect instructions for use (IFU) included.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RTI Surgical, Inc.
- Distributor
- International Distribution: Colombia only
- Lot
- Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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