Device recall
Z-2054-2013: Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915…
FDA device recall · Class II · Stryker Craniomaxillofacial Division
Key facts
| Recall number (Z-number) | Z-2054-2013 |
|---|---|
| Recall event | 65787 |
| Product | Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate… |
| Product code | GXP |
| Recalling firm | Stryker Craniomaxillofacial Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2014 |
| 510(k) numbers | K060763 |
| FEI number | 3005101424 |
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