The Recall Desk
ModerateFDA (Devices)·Z-2288-2015·Announced 2015-08-05

Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

The Anspach Effort, Inc. is recalling 91 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

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 labeling inconsistency regarding shaft exposure, which is a potential safety concern but does not involve reported injuries, fatalities, or high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 91 units of the ANSPACH 8MM x 14MM Fluted Drum, Side Cut Only (REF L-8DRC-G1). These medical devices are used for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers of this specific reference code.

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

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 of these devices should contact The Anspach Effort, Inc. for further instructions regarding the recall.

The recalled product

Product
ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
Affected units
91

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-8DRC-G1
  • ALLlot 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 →