Manufacturer

Osteotech Inc

12 recalls in our database name Osteotech Inc as the manufacturing or recalling firm.

What the numbers show

Total: 12
Critical: 0
Severe: 0
Most recent: 2012-10-24

Of the 12 recalls from Osteotech Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

HighFDA (Devices)·Z-0086-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0085-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0088-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0083-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0089-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0087-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0092-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0094-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0084-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0093-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0090-2013·2012-10-24
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
Medical Device
Distribution
Distributed nationwide