Device recall
Z-1148-2019: BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended…
FDA device recall · Class II · Bioventus, LLC
Key facts
| Recall number (Z-number) | Z-1148-2019 |
|---|---|
| Recall event | 82294 |
| Product | BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE. |
| Product code | MQV |
| Recalling firm | Bioventus, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2020 |
| 510(k) numbers | K132071 |
| FEI number | 3027669735 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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