Device product
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
Z-0591-2020
Product summary
- Event
- Event 84177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 387 units
- Official record key
device-enforcement:Z-0591-2020
Official wording
Reason: One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Code information: Lot Number NR1VM
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.