Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 92 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves labeling inconsistency regarding shaft exposure, which is a moderate risk factor without reported injuries.
Plain-English summary
The Anspach Effort, Inc. is recalling 92 units of ANSPACH 4MM x 11 MM Fluted Barrel, 14 Flutes (REF M-4BA-A-G1) dissection tools. These tools are used for cutting and shaping bone, including the spine and cranium. The recall affects 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. Additionally, the tools are labeled with a Specified Shaft Exposure that may not be consistent when used with each attachment listed on the label. This inconsistency may result in the actual shaft exposure being greater than what is indicated on the labeling.
The recalled 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 medical devices should stop using the affected tools and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 92
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-4BA-A-G1
- ALL lot numbers
Distribution
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.
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