Anspach Effort Pneumatic Systems Operating Manual Labeling Correction
Anspach Effort is correcting labeling on Pneumatic Systems Operating Manuals to remove unverified claims about cutting biometals, bioplastics, and cement.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is a Class II labeling correction where the hazard is theoretical and no illnesses or injuries are reported, fitting the criteria for a low-severity documentation issue.
Plain-English summary
The Anspach Effort, Inc. is initiating a correction of medical device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart, and Product Catalog. The affected products are utilized with BlackMax, MicroMax, and XMax Pneumatic Motor Systems, which are indicated for cutting and shaping bone.
The correction is being made because a recent review of regulations and compliance requirements determined that the claim that the device is capable of dissection of biometals, bioplastics, and cement is not part of the verified indications for use. The source text indicates that 2,020 units were distributed worldwide, including in the United States and numerous international locations.
Healthcare professionals and users of these pneumatic motor systems should review their operating manuals and product catalogs to ensure they are using the corrected labeling. The recall is limited to the documentation and labeling of the devices.
The recalled product
- Product
- Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
- 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 numbers 19-0005
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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