CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report

Anspach Cutting bur Diamond Ball, Standard Length recalled

The Anspach Effort is recalling Anspach Cutting bur Diamond Ball, Standard Length, distributed nationwide in the US. The recall was initiated on 8 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/Set/Serial: G323081803.

Quantity recalled30 cutting burs affected

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-1574-2014
FDA event ID: 68109
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 8 Jan 2014
FDA classified: 9 May 2014
Reported: 21 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

8 Jan 2014	Recall initiated by company
9 May 2014	Classified by FDA	+121 days
21 May 2014	Published in enforcement report	+12 days

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

Reason for recall

Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

Product as listed by the FDA

ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.

Where it was distributed

Nationwide Distribution including FL, TX, NC, IL, CO, and PA.

Nationwide Colorado Florida Illinois North Carolina Pennsylvania Texas

Questions about this recall

Is Anspach Cutting bur Diamond Ball, Standard Length recalled?

Yes. The Anspach Effort recalled Anspach Cutting bur Diamond Ball, Standard Length on 8 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-1574-2014.

Why was it recalled?

Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

Which lots are affected?

Lot/Set/Serial: G323081803.

Where was it sold?

Nationwide Distribution including FL, TX, NC, IL, CO, and PA.

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

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