Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 178 G1 dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure than labeled.
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 meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I). It is not a cosmetic defect, placing it at Moderate.
Plain-English summary
The Anspach Effort, Inc. is recalling 178 units of ANSPACH 5MM Fluted Ball, 2MM Shaft Exposure (REF S-5B-2-G1) cutting and shaping tools. These tools are used for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers.
The recall was initiated because the G1 dissection tools are not compatible with all attachments listed on the labeling. Additionally, the G1 cutting 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 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 should stop using the affected tools and contact the recalling firm for instructions.
The recalled product
- Product
- ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 178
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 S-5B-2-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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