The Recall Desk
ModerateFDA (Devices)·Z-2282-2015·Announced 2015-08-05

Anspach Extra Coarse Diamond Drum Recalled for Inconsistent Shaft Exposure

The Anspach Effort, Inc. is recalling 88 Extra Coarse Diamond Drums because the shaft exposure may be greater than labeled when used with certain attachments.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling inconsistency regarding shaft exposure without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 88 units of the ANSPACH Extra Coarse Diamond Drum, 6.8MM x 10.6MM (REF L-68DRMDX-G1). These medical devices are used for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers.

The recall was initiated because the G1 dissection tools are not compatible with all attachments listed on the labeling. Additionally, the G1 cutting tools are labeled with a Specified Shaft Exposure that may not be consistent when used with each attachment on the product label, potentially resulting in greater shaft exposure than indicated.

The products were distributed worldwide, including in the United States (AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX) and internationally to Canada and China. Users should stop using the affected tools and contact the recalling firm for instructions.

The recalled product

Product
ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
Affected units
88

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • REF L-68DRMDX-G1
  • ALL lot numbers

Distribution

Distributed in 17 states:

Part of a larger recall action

This product is one of 34 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 34 products in this recall →