Recall Z-1455-2015 ยท MQV Filler, Bone Void, Calcium Compound
Musculoskeletal Transplant Foundation, Inc.
DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
| Date | Apr 17, 2015 (initiated Dec 4, 2014) |
| Status | Terminated |
| Reason | The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact. |
| Root cause | Packaging process control |
| Action | MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter. |
| Quantity | 25 units |
| Distribution | US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040262 | DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX Musculoskeletal Transplant Foundation, Mar 17, 2005 |