FDA Device recall Z-2199-2016
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 Instr…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of 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 Instr… by Synthes Usa Products, citing dePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2199-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-31 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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.
Reason
DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.
Identifiers
| code_info | Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2199-2016%22
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