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.
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 compromise in a medical device used for bone grafting, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
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 intended for use as bone graft extenders, substitutes, and void fillers in the skeletal system. The recall involves 7,668 units that were distributed nationwide in the United States and internationally. Specific lot numbers are detailed in the attached documentation referenced in the recall notice.
Healthcare providers and patients should stop using the affected lots of Grafton and Xpanse. Consumers should contact their healthcare provider or the recalling firm for further instructions regarding the recall and potential replacement or refund options.
The recalled product
- 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
- Manufacturer
- Osteotech Inc
- Category
- Medical Device — Bone Graft
- Affected units
- 7,668
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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- HighOsteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
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