Anspach Effort Recalls G1 Dissection Tools Due to Labeling Inconsistencies
The Anspach Effort, Inc. is recalling 796 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 inconsistencies regarding shaft exposure, which is a potential safety issue but does not involve reported injuries or high-risk pathogens, fitting the Moderate severity criteria for labeling errors and precautionary measures.
Plain-English summary
The Anspach Effort, Inc. is recalling 796 units of the ANSPACH -4MM Carbide Fluted Ball, Extends 27MM (REF S-4BL-C-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. 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. As a result, the actual shaft exposure may be greater than what is specified 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 Anspach Effort, Inc. for further instructions.
The recalled product
- Product
- ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 796
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-4BL-C-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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