Medical device recalls Moderate risk

Brasseler USA I Lp recalls BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product…

Recall date
October 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0591-2020
FDA classification
Class II
Brand / firm
Brasseler USA I Lp
Sold / distributed
US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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