Drug recall
Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human…
FDA recall event 62569 · Class II · Osteotech Inc
Key facts
| Event ID | 62569 |
|---|---|
| Recall numbers | Z-0083-2013, Z-0084-2013, Z-0085-2013, Z-0086-2013, Z-0087-2013, Z-0088-2013, Z-0089-2013, Z-0090-2013, Z-0091-2013, Z-0092-2013, Z-0093-2013, Z-0094-2013 |
| Recalling firm | Osteotech Inc |
| Product type | Devices |
| Products | Grafton DBM A-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)…, Grafton DBM Crunch 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)…, 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…, Grafton DBM Gel 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…, Grafton DBM Matrix PLF 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)… and 6 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 20, 2012 |
| Report date | Oct 24, 2012 |
| Termination date | Jan 17, 2014 |
| City | Eatontown |
| State | NJ |
| Country | United States |
| FEI number | 2246640 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: