Optimum Expanse S 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 bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Multiple Lots - please see attachment
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Osteotech Inc
- Reason for Recall:
- Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Optimum Expanse S 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 bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
Product Codes/Lot Numbers:
Multiple Lots - please see attachment
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0094-2013
Related Recalls
Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.