Reported Dec 11, 2019 · Terminated

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

Brasseler USA I LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Brasseler USA I Lp · 1 Brasseler Blvd · Savannah, GA · 31419-9576

Is this the product you have?

  • BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm -
  • Product UsageTwist
  • drill intended useto drill into bone in hip or knee surgeries
Lot codes and dates
  • Lot Number NR1VM
Amount recalled
387 units

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 14, 2020 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.