Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk
The Anspach Effort, Inc. is voluntarily removing the microMax Pneumatic Drill System because the outer hose may 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 risk-of-harm product (potential hose rupture) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
The Anspach Effort, Inc. has initiated a voluntary removal of the microMax Pneumatic Drill System, which includes the motor handpiece 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 and is distributed worldwide, including in the United States and numerous international locations.
The recall was initiated because the handpiece's outer hose can rupture without warning if the air flow is blocked during use. This defect poses a risk of injury to users. The recall number is Z-0656-2014, and the affected serial number is MM900.
Consumers and healthcare providers should stop using the affected Pneumatic Drill System immediately. They should contact The Anspach Effort, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 1,224
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 MM900
Distribution
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.
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