Brasseler USA I Lp: Medical Device Recall in 2019 - (Recall #: Z-0591-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 18, 2019

Date Posted: December 11, 2019

Recall Number: Z-0591-2020

Event ID: 84177

Reason for Recall:

One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.

Status: Terminated

Product Quantity: 387 units

Code Information:

Lot Number NR1VM

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated