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 poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
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 recall involves 9,533 units across multiple lots. Grafton is intended for use as a bone graft extender, substitute, and void filler in the skeletal system.
Healthcare providers and patients should stop using the affected lots immediately and contact Osteotech Inc for instructions on how to return or dispose of the products.
The recalled product
- 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…
- Manufacturer
- Osteotech Inc
- Category
- Medical Device — Bone Graft
- Affected units
- 9,533
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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