Device recall
Z-2199-2016: Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-2199-2016 |
|---|---|
| Recall event | 74416 |
| Product | Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 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 |
| 510(k) numbers | K043310 |
| FEI number | 3008812560 |
At a glance
- 1–9 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