FDA Device recall Z-0085-2013
Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert ad…
- FDA Device
- Class II
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class II recall of Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert ad… by Osteotech, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0085-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-20 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Osteotech |
| Distribution | US |
Product
Grafton DBM Flex 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
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.
Identifiers
| code_info | Multiple Lots - please see attachment |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2013%22
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