FDA (Devices) recall action 62569

Osteotech Inc recalled 12 products on 2012-10-24

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2012-10-24
Critical: 0
Units: 36,205

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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
Category
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0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpans Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpans bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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 b
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpansé Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpansé bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpans Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpans bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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 substit
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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 gr
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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 gr
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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 bo
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
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 gra
Category
Distribution
0 states