Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Synthes (usa) Products Llc's record for this product code
Recent MDR events
229 adverse event reports on file
- HAND PIECE FOR BATTERY POWERED DRIVERFeb 21, 2023Malfunction2939274-2023-00007
- HANDLE BATTERY POWERED DRIVEROct 12, 2022Malfunction2939274-2022-03423
- HAND PIECE FOR BATTERY POWERED DRIVERSep 30, 2022Malfunction2939274-2022-03422
- HAND PIECE FOR BATTERY POWERED DRIVERSep 20, 2022Malfunction2939274-2022-03420
- HAND PIECE FOR BATTERY POWERED DRIVERSep 16, 2022Malfunction2939274-2022-03418
- 13.0MM CANNULATED DRILL BIT 300MMSep 2, 2022Malfunction2939274-2022-03403
- HAND PIECE FOR BATTERY POWERED DRIVERAug 19, 2022Malfunction2939274-2022-03278
- HAND PIECE FOR BATTERY POWERED DRIVERAug 12, 2022Malfunction2939274-2022-03228
- HAND PIECE FOR BATTERY POWERED DRIVERAug 12, 2022Malfunction2939274-2022-03234
- HAND PIECE FOR BATTERY POWERED DRIVERAug 12, 2022Malfunction2939274-2022-03235
Recalls
12 recall events for this product code
- TerminatedDec 1, 2016
Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗ - TerminatedJul 12, 2016
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.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Synthes (usa) Products Llc under this product code.