Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts
FDA Recall Z-0415-2012 · Posted 2012-01-11
Recalling FirmOsteotech Inc
Recall StatusTerminated
Product CodeMBP
Date Initiated2011-08-08
Date Terminated2011-12-08
Product Quantity15 units
Reason for Recall
Aseptic conditions during the production of these products may have been compromised.
Firm Action
Osteotech sent a recall letter dated August 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all units of the affected product. Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product.
For questions regarding this recall call 732-542-2800.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.