Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use
The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The devices are intended for cutting and shaping bone.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used on bone where fracture during use poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
The Anspach Effort, Inc. is recalling Anspach Carbide Cutting Burrs, including various cylindrical and fluted ball models, because some units fractured during use. The recalled products are intended for cutting and shaping bone, including the spine and cranium.
The recall includes 28,562 units of the affected products. These items were distributed worldwide, including nationwide in the United States (including Hawaii) and internationally to Australia, Poland, Canada, South Africa, Israel, and Switzerland. The affected lot numbers are those distributed within the 5-year expiration date range of December 13 through October 18.
Consumers and healthcare professionals should stop using the recalled burrs and contact The Anspach Effort, Inc. for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide…
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 28,562
Distribution
Part of a larger recall action
This product is one of 4 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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