The Recall Desk
ModerateFDA (Devices)·Z-2280-2015·Announced 2015-08-05

Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

The Anspach Effort, Inc. is recalling 65 Fluted Drum dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure.

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. The hazard involves inconsistent shaft exposure which may be greater than labeled, representing a potential safety risk without reported injuries or fatalities, fitting the Moderate criteria for labeling/consistency issues.

Plain-English summary

The Anspach Effort, Inc. is recalling 65 units of the ANSPACH Fluted Drum, Side Cut only 10MM x 14MM (REF L-10DRC-G1). These tools are used for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers for this specific reference code.

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

The affected 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 - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
65

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 (1)

  • REF L-10DRC-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 →

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