Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.
What this means for you
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 where indications were broader than validated, fitting the rubric for moderate severity involving labeling issues without reported injuries.
Plain-English summary
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The specific product identified is the MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM, which is intended for cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. A total of 212 units are included in this recall.
The recall was initiated after it was determined that the indications for use were broader than the validation of the MCA Cutting Burrs. Additionally, the directions for use did not clearly state the correct intended use of the device. The company has initiated a labeling correction to address these issues.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Belgium, Canada, Switzerland, Spain, France, the United Kingdom, Italy, Japan, the Netherlands, Sweden, and South Africa. Users of these medical devices should stop using them and contact the manufacturer for further instructions regarding the labeling correction.
The recalled product
- Product
- MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 212
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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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