Reported Jan 22, 2014 · Terminated

Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted…

The Anspach Effort, Inc.

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: The Anspach Effort, Inc. · 4500 Riverside Drive · Palm Beach Gardens, FL · 33410-4235

Is this the product you have?

  • Anspach Carbide Cutting Burrs2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Lot codes and dates
  • All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)
Amount recalled
28,562 total of all products in this recall

This recall covers 28 products

The agency filed one notice per product. You are reading one of them; the other 27 are below.

15 more are in the archive.

Where it was sold

  • Nationwide
  • HI

Why it was recalled

Some carbide cutting burr fractured during use.

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 May 9, 2016 · Data as of Sep 19, 6:06 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.