Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 99 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual usage, 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used on the spine and cranium where a labeling inconsistency could lead to unintended physical harm, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Anspach Effort, Inc. is recalling 99 units of ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure (REF S-4DC-22-G1). These tools are used for cutting and shaping bone, including the spine and cranium.
The recall was initiated because 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 on the product label, meaning the actual shaft exposure may be greater than stated.
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 manufacturer for instructions.
The recalled product
- Product
- ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 99
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-4DC-22-G1
- ALLlot 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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