Anspach Effort Recalls Pneumatic Systems Operating Manual and Product Catalog
Anspach Effort, Inc. is correcting labeling on its Pneumatic Systems Operating Manual and Product Catalog because a claim regarding the device's capability to dissect biometals, bioplastics, and cement was found to be inaccurate.
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: This is a Class II recall involving a labeling error where a claim was found to be inaccurate. The rubric classifies minor labeling errors and voluntary precautionary recalls as Moderate severity.
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 affects the Product Catalog (part number 20-0020) utilized with Electric and Pneumatic Motor Systems, including MicroMax, XMax, EMax2, and Emax2Plus Motor Systems, across all models and serial numbers. The products are indicated for use in cutting and shaping bone.
The recall was initiated following a review of regulations and compliance requirements. The review determined that the claim stating the device is capable of dissection of biometals, bioplastics, and cement has been verified but is not part of the approved indications. The source text indicates that 2,020 units were distributed worldwide, including the United States and numerous international locations.
Consumers and healthcare providers should verify the labeling on their Pneumatic Systems Operating Manuals and Product Catalogs. The source text does not specify specific consumer actions beyond the initiation of the labeling correction.
The recalled product
- Product
- Product Catalog (part number 20-0020) 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 cutting an
- 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 20-0020
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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