Anspach Micro Curved Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling Micro Curved Attachment Cutting Burrs because the 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 labeling errors where indications for use were broader than validated. No injuries or illnesses are reported, fitting the criteria for moderate severity.
Plain-English summary
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The product, identified by Part Number MCA and DFU 18-0001, is intended for cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. A total of 163 units were distributed worldwide, including the United States and international markets in Australia, Belgium, Canada, Switzerland, Spain, France, Great Britain, Italy, Japan, the Netherlands, Sweden, and South Africa.
The recall was initiated after the indications for use were found to be 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 recall was classified as Class II by the FDA.
Healthcare providers and consumers should stop using the affected devices. The source text indicates that a labeling correction was decided upon by the firm, but specific instructions for consumers or healthcare providers regarding the return or disposal of the devices are not provided in the available text.
The recalled product
- Product
- Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA 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
- 163
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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