Device recall
Z-0800-2013: Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty…
FDA device recall · Class II · Bacterin International, Inc.
Key facts
| Recall number (Z-number) | Z-0800-2013 |
|---|---|
| Recall event | 63433 |
| Product | Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created… |
| Product code | MBP |
| Recalling firm | Bacterin International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2013 |
| 510(k) numbers | K091321 |
| FEI number | 3005031160 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database