The Recall Desk
HighFDA (Devices)·Z-0727-2014·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 devices are intended for cutting and shaping bone.

What this means for you

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 Flut
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 →

Related recalls

Same manufacturer · The Anspach Effort, Inc.

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Same hazard · fracture

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