Device recall
Z-1250-2018: 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2…
FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1250-2018 |
|---|---|
| Recall event | 79418 |
| Product | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement. |
| Product code | LOD |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2019 |
| 510(k) numbers | K032945 |
| FEI number | 1811755 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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