FDA Medical Device Recalls (openFDA)
Osteotech Inc: 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
- Recall number
- Z-0415-2012
- 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
- Status
- Terminated
- Initiated
- 2011-08-08
- Posted
- 2012-01-11
- Terminated
- 2011-12-08
- Reason
- Aseptic conditions during the production of these products may have been compromised.
- 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
- 15 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Catalog Number A42150 Lot #OTSCT08 2845 exp 4/30/14 Catalog Number A4215000000000 Lot #OTSCT08 2845 exp 4/30/14
- 510(k) numbers
- ["K051195"]
- PMA numbers
- not on file
- Product code
- MBP
- Firm FEI
- 3002600221
- Firm city
- Eatontown
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28