Osteotech Inc: Medical Device Recall in 2012 - (Recall #: Z-0087-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Grafton DBM Crunch 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.

Product Classification:

Class II

Date Initiated: April 20, 2012

Date Posted: October 24, 2012

Recall Number: Z-0087-2013

Event ID: 62569

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.

Status: Terminated

Product Quantity: 3,541 units

Code Information:

Multiple Lots - please see attachment

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally.

Voluntary or Mandated:

Voluntary: Firm initiated