Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm Recalled by Brasseler USA I Lp Due to One lot of 3.5 mm twist drills were...

Date: October 18, 2019
Company: Brasseler USA I Lp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Brasseler USA I Lp directly.

Affected 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.

Quantity: 387 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Brasseler USA I Lp

Brasseler USA I Lp has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report