KM166 Twist Drill (Brasseler) – Laser Etching Error (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Brasseler USA I Lp
Lot Codes / Batch Numbers
Lot Number NR1VM
Products Sold
Lot Number NR1VM
Brasseler USA I Lp is recalling BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Leng due to One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Recommended Action
Per FDA guidance
Initial contact to customers was by telephone and visit on 18 October 2019. The firm followed with a letter disseminated by email on 10/25/2019. The firm is seeking return of the affected units and will replace them with correct devices.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026