Recall Z-1677-2011 ยท MQV Filler, Bone Void, Calcium Compound
Biostructures, LLC
OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.
| Date | Mar 16, 2011 (initiated Jan 31, 2011) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063527 | MBCP+ Biomatlante, Jul 30, 2007 |