Recall Z-0092-2013 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Osteotech Inc
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 int
| Date | Oct 18, 2012 (initiated Apr 20, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Osteotech sent out recall letters/questionairres dated April 20, 2012, to Risk Managers/service representatives. The recall was expanded on August 1 2012. The letter identified the product, the problem, and the action to be taken by the customer. Sales Representatives would facillitate the return of any affected product they may have or provide cautionary labels for any affected product and/or support in the completion of the attached questionnaire. Customers were asked to disseminate this information to additional personnel within their facility as appropriate and return the questionnaire |
| Quantity | 9,533 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally. |
| FDA record | Open on fda.gov |