The Recall Desk
HighFDA (Devices)·Z-2298-2015·Announced 2015-08-05

Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure

The Anspach Effort, Inc. is recalling 70 G1 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 a labeling inconsistency regarding shaft exposure could lead to unintended injury, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Anspach Effort, Inc. is recalling 70 units of ANSPACH 6MM Coarse Diamond Ball, 2 mm Shaft Exposure (REF M-6DC-2-G1). These tools are used for cutting and shaping bone, including the spine and cranium.

The recall was initiated 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 that may not be consistent when used with each attachment on the product label, potentially resulting in a greater shaft exposure than indicated.

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. All lot numbers are affected. Users should stop using the affected tools and contact the recalling firm for instructions.

The recalled product

Product
ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
70

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 M-6DC-2-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 →

Related recalls

Same manufacturer · The Anspach Effort, Inc.

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Same hazard · inconsistent labeling

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