Anspach Extra Coarse Diamond Drum Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 88 Extra Coarse Diamond Drums because the shaft exposure may be greater than labeled when used with certain attachments.
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, and the source text describes a labeling inconsistency regarding shaft exposure without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 88 units of the ANSPACH Extra Coarse Diamond Drum, 6.8MM x 10.6MM (REF L-68DRMDX-G1). These medical devices are used for cutting and shaping bone, including the spine and cranium. The recall covers 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 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 - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 88
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-68DRMDX-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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