Enforcement Report - Week of October 24, 2012
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Product Detail
| Product Description | Optimum Expanse S 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. |
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| Recall Number | Z-0094-2013 |
| Classification | Class II |
| Code Info | 510 K042707; K043048; K051188; K051195 Multiple Lots - please see attachment |
| Product Distributed Qty | 79,207 units for all products in recall event |
| 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. |
Event Detail
| Event Id | 62569 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Osteotech Inc |
| City | Eatontown |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and Internationally. |
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