The Recall Desk
SevereFDA (Devices)·Z-0726-2014·Announced 2014-01-22

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
28,562

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

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Same manufacturer · The Anspach Effort, Inc.

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