The Recall Desk
HighFDA (Devices)·Z-2305-2015·Announced 2015-08-05

Anspach G1 Dissection Tools Recalled Due to Inconsistent Shaft Exposure Labeling

The Anspach Effort, Inc. is recalling 70 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

What this means for you

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, posing a risk of harm to patients or operators, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

The Anspach Effort, Inc. is recalling 70 units of ANSPACH -3MM Coarse Diamond Ball, 72MM Shaft Exposure (REF S-3SDC-22-G1). These tools are used for cutting and shaping bone, including the spine and cranium. The recall affects all lot numbers of this specific reference number.

The recall was initiated because G1 dissection tools are not compatible with all attachments listed on the labeling. Additionally, the tools are labeled with a Specified Shaft Exposure that may not be consistent when used with each attachment listed on the product label. As a result, 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 should stop using these tools and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
70

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 S-3SDC-22-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 →

Related recalls

Same manufacturer · The Anspach Effort, Inc.

See all →

Same hazard · inconsistent labeling

See all →