FDA Medical Device Recalls (openFDA)
Biostructures, LLC: OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.
- Recall number
- Z-1677-2011
- Recalling firm
- Biostructures, LLC
- Product
- OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.
- Status
- Terminated
- Initiated
- 2011-01-31
- Posted
- 2011-03-16
- Terminated
- 2011-03-17
- Reason
- The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.
- Root cause
- Other
- Action
- An email was sent on 06/15/2010 to the firm's distributors that had products with lot #0809D110 or lot #0307I208 in their possesion. The email was in regards to the distributors' OMG10 granule inventory. The distributors need to return all the recalled granule inventory to be swapped out for new inventory.
- Quantity
- 248 units
- Distribution
- Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.
- Lot, serial or model codes
- OMG10/Lot # 0809D110 OMG10/Lot # 0307I208
- 510(k) numbers
- ["K063527"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3005449756
- Firm city
- Newport Beach
- Firm state
- CA
- 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