Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of 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, but the source text attributes the recall to labeling errors and unclear directions for use rather than reported injuries or hospitalizations, fitting the 'Moderate' criteria for minor labeling errors.
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 MCA5-06SD - 0.6MM Diamond Ball, 5.6CM, which is intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
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 device's directions for use did not clearly state the correct intended use. The company has decided to implement a labeling correction.
A total of 57 units 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 and labeling correction.
The recalled product
- Product
- MCA5-06SD - 0.6MM 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
- 57
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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