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 products 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the hazard involves a structural failure (fracture) of a medical device used on bone, which aligns with the rubric criteria for significant injury risk or structural defects.
Plain-English summary
The Anspach Effort, Inc. is recalling specific Anspach Carbide Cutting Burrs, including 2MM, 4MM, 5MM, and 7MM Carbide Fluted Ball models. The recall involves a total of 28,562 units. These products 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 lot numbers were distributed within the 5-year expiration date, ranging from 12/13 to 10/18.
The products were distributed worldwide, including nationwide in the United States (including Hawaii) and internationally to Australia, Poland, Canada, South Africa, Israel, and Switzerland. Users should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach…
- 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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