Z-1677-2011

OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use

Name: Z-1677-2011 OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use
Creator: Biostructures, LLC
Published: 2011-01-31
License: https://open.fda.gov/license/

Biostructures, LLC / initiated 2011-01-31 / Terminated / root cause: labeling and UDI

FDA source

Biostructures, LLC began a recall of OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use on 2011-01-31. The reason FDA records is "The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1677-2011
Status: Terminated
Initiated: 2011-01-31
Posted: 2011-03-16
Terminated: 2011-03-17
Recalling firm: Biostructures, LLC
Product: OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 248 units
Distribution: Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.
Product codes and lots: OMG10/Lot # 0809D110 OMG10/Lot # 0307I208

Product code MQV

K063527Class IIMbcp+Biomatlante / cleared 2007-07-30

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)