The Recall Desk
HighFDA (Devices)·Z-2283-2015·Announced 2015-08-05

Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

The Anspach Effort, Inc. is recalling 177 fluted drum dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for cutting bone where the shaft exposure may be greater than labeled, creating a risk of harm (injury) that has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

The Anspach Effort, Inc. is recalling 177 units of the ANSPACH Fluted Drum, Side Cut only, 6MM x 14MM (REF L-6DRC-G1). These tools are used for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers.

The recall is being issued because the G1 dissection tools are not compatible with all attachments listed on the labeling. Specifically, the G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. The actual shaft exposure may be greater than what is indicated on the label.

The affected tools 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 on return or replacement.

The recalled product

Product
ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
177

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-6DRC-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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