The Recall Desk
HighFDA (Devices)·Z-0655-2014·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 outer hose can rupture without warning if airflow is blocked.

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 risk-of-harm product (potential hose rupture) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

The Anspach Effort, Inc. has initiated a voluntary removal of its 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 product is intended for cutting and shaping bone.

The recall was initiated because the hand piece's outer hose can rupture without warning if the air flow is blocked during use. The source text does not report any specific injuries or illnesses associated with this defect.

The recall covers 976 units distributed nationwide in the United States, including Puerto Rico, and internationally to numerous countries. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
976

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 G11307654403

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 →

Related recalls

Same manufacturer · The Anspach Effort, Inc.

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Same hazard · hose rupture

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