Osteotech Inc Recall: Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a huma
Osteotech Inc Recall: Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a huma is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Osteotech Inc; Product: Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human
| Recalling firm | Osteotech Inc |
|---|---|
| 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 graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) 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. |
| 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 II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally. |
| Recall initiated | 20120420 |
| Recall number | Z-0092-2013 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
Try RecallGuard →