The Recall Desk
ModerateFDA (Devices)·Z-2297-2015·Announced 2015-08-05

Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

The Anspach Effort, Inc. is recalling 95 G1 dissection tools because the labeled shaft exposure may not be consistent with all listed attachments, 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, which typically corresponds to a moderate severity. The hazard involves inconsistent labeling regarding shaft exposure, which is a safety concern but does not explicitly report injuries or deaths in the source text, fitting the criteria for a moderate risk of harm.

Plain-English summary

The Anspach Effort, Inc. is recalling 95 units of ANSPACH 6MM x 11.3MM Fluted Barrel cutting and shaping tools, reference number M-6BA-A-G1. These tools are designed for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers of this specific reference model.

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

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 of these tools should stop using them and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine and cranium.
Affected units
95

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-6BA-A-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 →