Anspach Fluted Barrel Dissection Tools Recalled for Labeling Inconsistency
The Anspach Effort, Inc. is recalling 110 fluted barrel dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
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 and attachment compatibility, which is a moderate risk without reported injuries or fatalities.
Plain-English summary
The Anspach Effort, Inc. is recalling 110 units of the ANSPACH Fluted Barrel (8MM x 12.5MM, REF L-8BA-G1). These 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, potentially resulting in greater shaft exposure than indicated.
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 instructions.
The recalled product
- Product
- ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 110
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-8BA-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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