Device recall
Z-2206-2012: Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S…
FDA device recall · Class I · Synthes USA HQ, Inc.
Key facts
| Recall number (Z-number) | Z-2206-2012 |
|---|---|
| Recall event | 62592 |
| Product | Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces. |
| Product code | MTJ |
| Recalling firm | Synthes USA HQ, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 6, 2015 |
| 510(k) numbers | K103822, K113079 |
| FEI number | 3005180112 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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