Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
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 for use were broader than validation. No injuries or illnesses are reported, fitting the criteria for a moderate severity labeling issue.
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 MCA5-1SB - 1MM Fluted Ball, 5.6CM. A total of 76 units are included in this recall.
The recall was initiated after the company 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 product is intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
The affected devices were distributed worldwide, including nationwide in the US and internationally to Australia, Belgium, Canada, Switzerland, Spain, France, the United Kingdom, Italy, Japan, the Netherlands, Sweden, and South Africa. The source text does not specify further instructions for consumers or healthcare providers beyond the initiation of the recall.
The recalled product
- Product
- MCA5-1SB - 1MM Fluted 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
- 76
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 are included in recall
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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