Anspach Effort Recalls Cutting Bur Chart Due to Labeling Error
Anspach Effort, Inc. is correcting labeling on its Cutting Bur Chart and related manuals because a claim about cutting biometals was not part of the device's intended use.
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, which typically corresponds to a moderate severity. The issue is a labeling error regarding the device's intended use, which is a minor labeling error without reported injuries or illnesses.
Plain-English summary
The Anspach Effort, Inc. has initiated a correction of its medical device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart, and Product Catalog. This action was taken after a review of regulations and compliance requirements determined that a claim stating the device is capable of dissection of biometals, bioplastics, and cement is not part of the device's intended use.
The affected product is the Cutting Bur Chart (part number 20-0019), which is utilized with various Electric and Pneumatic Motor Systems, including MicroMax, XMax, EMax2, and Emax2Plus models. The indication for use is cutting and shaping bone. The recall covers 2,020 units distributed worldwide, including the United States and numerous international locations.
Consumers and healthcare providers should verify the labeling on their manuals and charts to ensure they do not contain the incorrect claim regarding the dissection of biometals, bioplastics, or cement. The recall is a labeling correction to ensure compliance with regulatory requirements.
The recalled product
- Product
- Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is…
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 2,020
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)
- part number 20-0019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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