Device recall
Z-2189-2016: Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-2189-2016 |
|---|---|
| Recall event | 74416 |
| Product | Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant. |
| Product code | HWE |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2017 |
| FEI number | 3008812560 |
At a glance
- None Linked 510(k)s
- 10–99 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