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.
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, 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.
- 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
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
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