CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report

Anspach - Extra Coarse Diamond Drum recalled by The Anspach Effort

The Anspach Effort is recalling Anspach - Extra Coarse Diamond Drum, distributed nationwide in the US. The recall was initiated on 13 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF L-68DRMDX-G1 ; ALL lot numbers

Quantity recalled88 tools.

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-2282-2015
FDA event ID: 71212
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2015
FDA classified: 29 Jul 2015
Reported: 5 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

13 Apr 2015	Recall initiated by company
29 Jul 2015	Classified by FDA	+107 days
5 Aug 2015	Published in enforcement report	+7 days

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

Reason for recall

G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.

Where it was distributed

Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.

Nationwide Arizona California Colorado Florida Georgia Illinois Kentucky Louisiana Minnesota Missouri North Carolina New Jersey New York Ohio Oregon Pennsylvania Texas

Questions about this recall

Is Anspach - Extra Coarse Diamond Drum recalled?

Yes. The Anspach Effort recalled Anspach - Extra Coarse Diamond Drum on 13 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-2282-2015.

Why was it recalled?

Which lots are affected?

REF L-68DRMDX-G1 ; ALL lot numbers

Where was it sold?

Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.

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

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Device	CLASS II	Adult Craniotome recalled by The Anspach Effort	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
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
18 Jan 2023Device	CLASS II	Large Craniotome Attachment Use with XMax¿, microMax recalled	The Anspach Effort	Processing Deviation	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide