FDAClass IIDecember 11, 2019

BRASSELER KM166-310-35 Twist Drill Quick Connect recall

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

Why was BRASSELER KM166-310-35 Twist Drill Quick Connect recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number NR1VM

Product
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended…
Recalling firm
Brasseler USA I Lp
Quantity
387 units
Distribution
US Nationwide distribution.
Recall date
December 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls