Device recall
Z-1526-2020: OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE…
FDA device recall · Class II · XTANT MEDICAL INC
Key facts
| Recall number (Z-number) | Z-1526-2020 |
|---|---|
| Recall event | 85036 |
| Product | OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps… |
| Product code | MBP |
| Recalling firm | XTANT MEDICAL INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2020 |
| 510(k) numbers | K130498 |
| 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