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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Product Detail

Product Description Grafton DBM Putty 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.
Recall Number Z-0083-2013
Classification Class II
Code Info 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment
Product Distributed Qty 79,207 units for all products in recall event
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.

Event Detail

Event Id 62569
Product Type Devices
Status Ongoing
Recalling Firm Osteotech Inc
City Eatontown
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally.
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