Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft… — Class II medical device recall Z-0083-2013
Terminated recall by Osteotech Inc, reported 2012-10-24, distributed nationwide. Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled becaus
| Recall number | Z-0083-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Osteotech Inc, Eatontown, NJ, United States |
| Recall initiated | 2012-04-20 |
| Classified | 2012-10-18 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2014-01-17 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
Product
Grafton DBM Putty 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0083-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.