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 identifies the issue as a labeling error where indications for use were broader than validation, with no reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate score.
Plain-English summary
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device.
The recalled product is the MCA7-05SD - 0.5MM Diamond Ball, 7.3CM, intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. A total of 6,439 units were distributed worldwide, including the United States and internationally to Australia, Belgium, Canada, Switzerland, Spain, France, Great Britain, Italy, Japan, the Netherlands, Sweden, and South Africa.
The source text indicates that a labeling correction was decided upon by the firm. No specific instructions for consumers or healthcare providers are provided in the available text regarding how to return the product or what immediate actions to take.
The recalled product
- Product
- MCA7-05SD - 0.5MM 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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