The Recall Desk
SevereFDA (Devices)·Z-0654-2014·Announced 2014-01-15

Anspach Pneumatic Drill System Recalled Due to Hose Rupture Risk

The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems from the market because the outer hose on the motor hand-piece can rupture without warning if air flow is blocked.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect (hose rupture) that poses a significant risk of injury to patients during surgical procedures, meeting the criteria for a Severe rating.

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 is due to a defect where the hand piece's outer hose can rupture without warning if the air flow is blocked during use. The affected units are identified by Serial Number 31496602.

The recall covers 2,785 units that were distributed nationwide in the United States, including Puerto Rico, and internationally to numerous countries. The product is intended for cutting and shaping bone and is available by prescription only.

Consumers and healthcare providers should stop using the affected Pneumatic Drill Systems immediately. The firm is responsible for the removal of these units from the market.

The recalled product

Product
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
2,785

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 31496602

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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