FDA recall Z-0591-2020

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.

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2019-10-18

Report date

2019-12-11

Termination date

2020-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Savannah, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2020