CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report

Anspach Carbide Cutting Burrs & Drums recalled by The Anspach Effort

The Anspach Effort is recalling Anspach Carbide Cutting Burrs & Drums: Cylindrical Carbide Drum part # S-15DRMC Anspach, distributed nationwide in the US. The recall was initiated on 17 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)

Quantity recalled28,562 total of all products in this recall

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0728-2014
FDA event ID: 67146
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 17 Dec 2013
FDA classified: 13 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

17 Dec 2013	Recall initiated by company
13 Jan 2014	Classified by FDA	+27 days
22 Jan 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Some carbide cutting burr fractured during use.

Product as listed by the FDA

Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

Where it was distributed

Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.

Nationwide Hawaii

Questions about this recall

Is Anspach Carbide Cutting Burrs & Drums: Cylindrical Carbide Drum part # S-15DRMC Anspach recalled?

Yes. The Anspach Effort recalled Anspach Carbide Cutting Burrs & Drums: Cylindrical Carbide Drum part # S-15DRMC Anspach on 17 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0728-2014.

Why was it recalled?

Some carbide cutting burr fractured during use.

Which lots are affected?

All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)

Where was it sold?

Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from The Anspach Effort

All 260

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18 Jan 2023Device	CLASS II	Adult Craniotome recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
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18 Jan 2023Device	CLASS II	Adult Craniotome, Thin Foot Plate Attachment recalled	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
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