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.
What this means for you
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 failure in a medical device used in surgical procedures, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Osteotech Inc is recalling multiple lots of Grafton and Xpans, 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 detailed in an attachment referenced in the official recall notice.
Healthcare providers and patients should stop using these products and contact Osteotech Inc for further instructions or a return.
The recalled product
- 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
- Manufacturer
- Osteotech Inc
- Category
- Medical Device — Bone Graft
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
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See all →- HighOsteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
FDA (Devices) · 2012-10-24
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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
- HighOsteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
FDA (Devices) · 2012-10-24
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