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Osteotech Inc recalls Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tiss
Recalled October 24, 2012 · FDA recall Z-0086-2013 · Osteotech
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. · FDA Class II
Units
215 units
Sold at
Worldwide Distribution - USA (nationwide) and Internationally.
Description
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.
Product
Grafton DBM A-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.
Manufacturer(s)
Osteotech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →