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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description 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
Recall Number Z-0729-2014
Classification Class II
Code Info All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)
Product Distributed Qty 28,562 products for the entire recall
Reason For Recall Some carbide cutting burr fractured during use.

Event Detail

Event Id 67146
Product Type Devices
Status Ongoing
Recalling Firm The Anspach Effort, Inc.
City Palm Beach Gardens
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.