DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
FDA device recall Z-1455-2015 · posted 2015-04-17 · Terminated
Recall details
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- Reason for recall
- The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.
- Action taken
- MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 25 units
- Distribution
- US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
- Date initiated
- 2014-12-04
- Date posted
- 2015-04-17
- Date terminated
- 2017-05-08
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX (K040262) | Musculoskeletal Transplant Foundation | 2005-03-17 |