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

MCA5-2SD - Diamond Ball All lots are included in recall recalled

The Anspach Effort is recalling MCA5-2SD - Diamond Ball All lots are included in recall, distributed nationwide in the US. The recall was initiated on 29 Mar 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots are included in recall

Quantity recalled6439 total

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-0759-2014
FDA event ID: 63624
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 29 Mar 2012
FDA classified: 14 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Mar 2012	Recall initiated by company
14 Jan 2014	Classified by FDA	+656 days
22 Jan 2014	Published in enforcement report	+8 days

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

Reason for recall

The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide

Product as listed by the FDA

MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.

Where it was distributed

Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.

Nationwide California

Questions about this recall

Is MCA5-2SD - Diamond Ball All lots are included in recall recalled?

Yes. The Anspach Effort recalled MCA5-2SD - Diamond Ball All lots are included in recall on 29 Mar 2012. The recall is Class II and its status is Terminated. Recall number Z-0759-2014.

Why was it recalled?

Which lots are affected?

All lots are included in recall

Where was it sold?

Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.

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.

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