FDAClass IIFebruary 5, 2014

AnspacSingle use Sterile bone cutting burs.h recall

AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

Why was AnspacSingle use Sterile bone cutting burs.h recalled?

Cutter was longer than was stated on the label

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 #'s: D293037349, D323038110 and D363039140

Product
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Recalling firm
The Anspach Effort, Inc.
Quantity
599 cutting burs
Distribution
Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
Recall date
February 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls