Device product
Grafton DBM Orthoblend Large Defect 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.
Z-0091-2013
Product summary
- Firm
- Osteotech Inc
- Event
- Event 62569
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,274 units
- Official record key
device-enforcement:Z-0091-2013
Official wording
Reason: 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.
Code information: Multiple Lots - please see attachment
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally.
Derived failure modes
-
Unknown
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.