The Recall Desk
ModerateFDA (Devices)·Z-2292-2015·Announced 2015-08-05

Anspach G1 Dissection Tools Recalled Due to Inconsistent Shaft Exposure Labeling

The Anspach Effort, Inc. is recalling 142 G1 dissection tools because the labeled shaft exposure may not be consistent with all listed 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a labeling inconsistency regarding shaft exposure, which fits the criteria for a moderate severity recall involving labeling errors without reported harm.

Plain-English summary

The Anspach Effort, Inc. is recalling 142 units of the ANSPACH 3MM Course Diamond Ball, 2 MM Shaft Exposure (REF M-3DC-2-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 number.

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 what is indicated 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 stop using them and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.
Affected units
142

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-3DC-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 →