The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2284-2015·Announced 2015-08-05

Anspach Fluted Acorn Dissection Tools Recalled for Inconsistent Shaft Exposure

The Anspach Effort, Inc. is recalling 227 Fluted Acorn 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 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 inconsistent shaft exposure labeling which could lead to unexpected tool behavior, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 227 units of the ANSPACH Fluted Acorn, 7MM (REF L-7AC-G1) dissection tools. These tools 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. Specifically, 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. The actual shaft exposure may be greater than what is indicated on the label.

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 Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
227

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-7AC-G1
  • ALL lot numbers

Distribution

Distributed in 17 states:

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.

See all 34 products in this recall →

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