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.
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 medical device with a potential sterility compromise, 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. These products are intended for use as bone graft extenders, substitutes, and void fillers in the skeletal system.
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 source text does not specify the number of affected units, specific lot numbers, or the exact dates of distribution.
The products were distributed worldwide, including nationwide in the United States and internationally. Healthcare providers and patients who have used or are scheduled to use these products should contact their healthcare provider or Osteotech Inc for further instructions.
The recalled product
- 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
- 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
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
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12