Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 88 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 safety concern but does not involve reported injuries or high-risk pathogens, fitting the Moderate criteria for labeling errors and precautionary measures.
Plain-English summary
The Anspach Effort, Inc. is recalling 88 units of the ANSPACH 4MM Fluted Ball, Extends 27MM (REF M-4B-27-G1). These tools 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. Additionally, the tools are labeled with a Specified Shaft Exposure that may not be consistent when used with each attachment listed on the product label. The actual shaft exposure may be greater than the specified amount.
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 should stop using the affected tools and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 88
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-4B-27-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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