Anspach 5MM Fluted Ball Dissection Tools Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 79 Anspach 5MM Fluted Ball 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 is classified as FDA Class II, and the hazard involves a risk of harm (inconsistent shaft exposure) in a high-risk medical device used on bone, without reported injuries in the source text.
Plain-English summary
The Anspach Effort, Inc. is recalling 79 units of the ANSPACH 5MM Fluted Ball, 2 mm Shaft Exposure (REF M-5B-2-G1). These medical devices are used for cutting and shaping bone, including the spine and cranium. The recall covers all lot numbers of this specific reference model.
The recall was initiated because the G1 dissection tools are not compatible with all attachments listed on the product labeling. Specifically, the tools are labeled with a Specified Shaft Exposure that may not be consistent when used with each attachment listed on the label. In some cases, the actual shaft exposure may be greater than the specified amount.
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 of these medical devices should stop using the affected tools and contact the manufacturer for further instructions.
The recalled product
- Product
- ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 79
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 M-5B-2-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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