Agency classClass IIOur severity:High FDA (Devices)·Z-0657-2014·Announced 2014-01-15

Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk

The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems because the handpiece hose can rupture without warning if airflow is blocked.

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 with a risk of harm (hose rupture) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

The Anspach Effort, Inc. has initiated a voluntary removal of the Pneumatic Drill System, which includes the motor hand-piece and Auto Lube foot control. The recall affects units that do not have a pressure relief valve (PRV).

The recall is being conducted because the handpiece's outer hose can rupture without warning if the air flow is blocked during use. The product is intended for cutting and shaping bone and is distributed worldwide, including in the United States and numerous international locations.

Consumers and healthcare providers should stop using the affected Pneumatic Drill Systems immediately. The specific serial number identified in the recall notice is F37306977201. Users should contact the manufacturer for further instructions on the removal process.

The recalled product

Product: ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Manufacturer: The Anspach Effort, Inc.
Category: Medical Device — Surgical Instruments
Hazard: hose-rupture
pressure-hazard
Affected units: 12

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 (1)

Serial Number F37306977201

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · The Anspach Effort, Inc.

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Same hazard · hose rupture