OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.
FDA device recall Z-1677-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- Biostructures, LLC
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 248 units
- Distribution
- Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.
- Date initiated
- 2011-01-31
- Date posted
- 2011-03-16
- Date terminated
- 2011-03-17
- Location
- Newport Beach, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MBCP+ (K063527) | Biomatlante | 2007-07-30 |