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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential sterility compromise in a medical device used in surgical procedures, which presents a risk of harm (infection) even though no illnesses or injuries have been reported yet, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Osteotech Inc is recalling multiple lots of Grafton and Xpanse, which are human bone allograft products used for bone grafting procedures. The recall is being conducted because there is a possibility that the sterility of the outer surface of the inner pouch may become compromised.
The affected products are distributed worldwide, including nationwide in the United States and internationally. The specific lot numbers are listed in an attachment to the official recall notice. The source text does not specify the exact number of units affected or the specific dates of distribution.
Healthcare providers and patients who have used or are scheduled to use these products should contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- 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…
- Manufacturer
- Osteotech Inc
- Category
- Medical Device — Bone Graft
- Affected units
- 3,541
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Multiple Lots - please see attachment
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Osteotech Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Osteotech Inc
See all →- HighOsteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
FDA (Devices) · 2012-10-24
- HighOsteotech Recalls Grafton and Xpans Bone Graft Products Due to Sterility Concerns
FDA (Devices) · 2012-10-24
- HighOsteotech Recalls Grafton and Xpansé Bone Graft Products Due to Sterility Concerns
FDA (Devices) · 2012-10-24
- HighOsteotech Recalls Grafton and Xpans Bone Graft Products Due to Sterility Concerns
FDA (Devices) · 2012-10-24
- HighOsteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
FDA (Devices) · 2012-10-24
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