Z-0415-2012

Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone...

Name: Z-0415-2012 Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone...
Creator: Osteotech Inc
Published: 2011-08-08
License: https://open.fda.gov/license/

Osteotech Inc / initiated 2011-08-08 / Terminated / root cause: manufacturing process

FDA source

Osteotech Inc began a recall of 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 on 2011-08-08. The reason FDA records is "Aseptic conditions during the production of these products may have been compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0415-2012
Status: Terminated
Initiated: 2011-08-08
Posted: 2012-01-11
Terminated: 2011-12-08
Recalling firm: Osteotech Inc
Product: 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
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Reason for recall: Aseptic conditions during the production of these products may have been compromised.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
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.
Quantity in commerce: 15 units
Distribution: Worldwide Distribution
Product codes and lots: Catalog Number A42150 Lot #OTSCT08 2845 exp 4/30/14 Catalog Number A4215000000000 Lot #OTSCT08 2845 exp 4/30/14

Product code MBP

K051195Class IIGrafton DbmOsteotech, Inc. / cleared 2005-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)