Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use
The Anspach Effort, Inc. is recalling carbide cutting burrs and drums because some fractured during use. The products are used 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 no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
The Anspach Effort, Inc. is recalling Anspach Carbide Cutting Burrs & Drums, specifically the 1.5MM x 7.5MM Cylindrical Carbide Drum (part # S-15DRMC). The recall involves 28,562 total units of all products in this recall. These medical devices are intended for cutting and shaping bone, including the spine and cranium.
The recall was initiated because some carbide cutting burrs fractured during use. The affected products were distributed worldwide, including nationwide in the United States (including Hawaii) and internationally to Australia, Poland, Canada, South Africa, Israel, and Switzerland. All lot numbers distributed within the 5-year expiration date (12/13 thru 10/18) are included in this recall.
Healthcare professionals and consumers should stop using the affected products immediately. The recalling firm, The Anspach Effort, Inc., is responsible for managing the recall.
The recalled product
- Product
- Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
- Manufacturer
- The Anspach Effort, Inc.
- 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.
See all 4 products in this recall →Related recalls
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