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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Grafton DBM Flex 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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0085-2013
Grafton DBM Gel 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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0084-2013
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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0083-2013
Optimum Expanse S 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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0094-2013
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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0093-2013
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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0092-2013
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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0091-2013
Grafton DBM Orthoblend Small 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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0090-2013
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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0089-2013
Grafton DBM Matrix PLF 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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0088-2013
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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0087-2013
Grafton DBM A-Flex 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. 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment Class II 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. 79,207 units for all products in recall event Z-0086-2013
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