Z-0093-2013 Class II Terminated
FDA device recall Z-0093-2013 was initiated by Osteotech Inc on April 20, 2012 and is designated Class II. Reason for recall: 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 becom… The recall status is terminated (terminated January 17, 2014). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2012
- Initiation Date
- April 20, 2012
- Termination Date
- January 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Optimum Expanse R 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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally.
Code Information
Multiple Lots - please see attachment