Anspach Fluted Ball Dissection Tools Recalled for Labeling Inconsistency
The Anspach Effort, Inc. is recalling 353 Fluted Ball dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
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, but the source text describes a labeling inconsistency regarding shaft exposure without reporting any injuries, illnesses, or specific harm. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues where no adverse events are reported.
Plain-English summary
The Anspach Effort, Inc. is recalling 353 units of the ANSPACH Fluted Ball (REF L-9B-G1), a 9mm tool used for cutting and shaping bone, including the spine and cranium. The recall was initiated because the G1 dissection tools are not compatible with all attachments listed on the product labeling. Additionally, the tools are labeled with a Specified Shaft Exposure that may not be consistent when used with each attachment, potentially resulting in greater shaft exposure than indicated.
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. The recall covers all lot numbers for REF L-9B-G1.
Users of these dissection tools should stop using the product and contact The Anspach Effort, Inc. for further instructions.
The recalled product
- Product
- ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 353
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-9B-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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