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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
Recall Number Z-1659-2013
Classification Class II
Code Info SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
Product Distributed Qty 61 units
Reason For Recall The RPM of the Motor Handpiece may be less than 80,000 RPM.

Event Detail

Event Id 64973
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 2011-06-24
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
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