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 recall covers 28,562 units distributed worldwide.
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 the spine and cranium that fractured during use. This represents a risk-of-harm product where injury has not yet been explicitly reported in the source text, fitting the High severity criteria.
Plain-English summary
The Anspach Effort, Inc. is recalling 28,562 units of Anspach Carbide Cutting Burrs & Drums, specifically the 2MM Carbide Fluted Ball, Extended (part # S-2B-C) and 7MM Carbide Fluted Ball (part # S-7B-C). These medical devices are intended for cutting and shaping bone, including the spine and cranium.
The recall was initiated because some of the 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. The recall includes all lot numbers distributed within the 5-year expiration date, ranging from 12/13 through 10/18.
Healthcare providers and consumers should stop using these specific burrs immediately. The recalling firm, The Anspach Effort, Inc., is responsible for managing the recall and providing further instructions to affected parties.
The recalled product
- Product
- Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C 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.
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