Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 177 fluted drum dissection tools 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 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 medical device used for cutting bone where the shaft exposure may be greater than labeled, creating a risk of harm (injury) that has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
The Anspach Effort, Inc. is recalling 177 units of the ANSPACH Fluted Drum, Side Cut only, 6MM x 14MM (REF L-6DRC-G1). These tools are used for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers.
The recall is being issued because the G1 dissection tools are not compatible with all attachments listed on the labeling. Specifically, the G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. The actual shaft exposure may be greater than what is indicated on the label.
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. Users should stop using the affected tools and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 177
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-6DRC-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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