Anspach Diamond Ball Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 72 Anspach Extra Coarse Diamond Ball tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.
What this means for you
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 error regarding shaft exposure could lead to unintended injury, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Anspach Effort, Inc. is recalling 72 units of the Anspach Extra Coarse Diamond Ball (Reference L-8DX-G1). These 8mm tools are used for cutting and shaping bone, including the spine and cranium. The recall affects 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 on the product label. As a result, the actual shaft exposure may be greater than what is indicated on the label.
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 further instructions.
The recalled product
- Product
- ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 72
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 L-8DX-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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