Home / Recalls / Osteotech Inc / Z-0089-2013

Z-0089-2013 Class II Terminated

Recalled by Osteotech Inc — Eatontown, NJ

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
4,117 units

Product Description

Grafton DBM Matrix Strips 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.

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

Other recalls by Osteotech Inc

  • Z-0093-2013 Class II — Optimum Expanse R Grafton is a human bone allograft product containing demine (April 20, 2012)
  • Z-0088-2013 Class II — Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft prod (April 20, 2012)
  • Z-0091-2013 Class II — Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone (April 20, 2012)
  • Z-0085-2013 Class II — Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product co (April 20, 2012)
  • Z-0086-2013 Class II — Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product (April 20, 2012)
  • Z-0094-2013 Class II — Optimum Expanse S Multiple sizes Grafton is a human bone allograft product c (April 20, 2012)
  • Z-0084-2013 Class II — Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product con (April 20, 2012)
  • Z-0083-2013 Class II — Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product c (April 20, 2012)
  • Z-0092-2013 Class II — Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone (April 20, 2012)
  • Z-0087-2013 Class II — Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product (April 20, 2012)