Anspach MCA Cutting Burr Recalled for Inadequate Labeling Instructions
The Anspach Effort, Inc. is recalling MCA Cutting Burs because the current directions for use do not provide sufficient details regarding the intended use for these specific burs.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (inadequate directions for use) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 492 units of Anspach MCA Cutting Burs (item 18-0001). These medical devices are designed for cutting and shaping delicate bone, primarily in otology procedures. The recall covers all lots for product code 18-0001.
The recall was initiated because the current directions for use do not provide enough details regarding the intended use specifically for the MCA burs. This is a labeling deficiency that may affect the clarity of how the device is meant to be used.
The affected units were distributed nationwide in the United States and internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and the Netherlands. Users of these devices should contact the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
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)
- ALL LOTS for product code 18-0001
Distribution
Distributed nationwide across the United States.
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