FDAFDA · Food and drugs·Recall number Z-0085-2013
Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
Published October 24, 2012 · Recall initiated: April 20, 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
Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Osteotech Inc
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally.
- Lot
- Multiple Lots - please see attachment
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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