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 validated and directions were unclear.
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 is driven by labeling errors where indications for use were broader than validated. There are no reports of injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
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 MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. A total of 6,439 units are included in this recall. These devices are 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 directions for use did not clearly state the correct intended use of the device. The company is implementing 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, Great Britain, Italy, Japan, the Netherlands, Sweden, and South Africa. Users of these devices should stop using them and contact the manufacturer for further instructions regarding the labeling correction.
The recalled product
- Product
- MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. 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
- 6,439
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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