Home / Recalls / Medical Devices
Brasseler USA I Lp recalls BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product U
Recalled December 11, 2019 · FDA recall Z-0591-2020 · Brasseler USA I
Hazard
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. · FDA Class II
Units
387 units
Sold at
US Nationwide distribution.
Description
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the 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.
Manufacturer(s)
Brasseler USA I Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →