The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2308-2015·Announced 2015-08-05

Anspach 4mm Diamond Ball Dissection Tool Recall for Inconsistent Shaft Exposure

The Anspach Effort, Inc. is recalling 246 units of the 4mm Diamond Ball dissection tool 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 on the spine and cranium where the shaft exposure may be greater than labeled, creating a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

The Anspach Effort, Inc. is recalling 246 units of the ANSPACH 4MM Diamond Ball, Extends 27MM (REF S-4D-L-G1). The recall covers all lot numbers of this product, which is used for cutting and shaping bone, including the spine and cranium.

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 units 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 product and contact the recalling firm for instructions.

The recalled product

Product
ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
246

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-4D-L-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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