Device recall
Z-2536-2016: Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000…
FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-2536-2016 |
|---|---|
| Recall event | 74582 |
| Product | Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber… |
| Product code | NDN |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2017 |
| 510(k) numbers | K150582 |
| FEI number | 1811755 |
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