The Recall Desk
HighFDA (Devices)·Z-0729-2014·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 recall covers 28,562 units distributed worldwide.

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 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.
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.

See all →

Same hazard · fracture

See all →