FDA-Device2019-12-11Class II
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.
Brasseler USA I Lp
Hazard
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Sold states
US Nationwide distribution.
Affected count
387 units
Manufactured in
1 Brasseler Blvd, Savannah, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2020Don't want to check this manually?
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