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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description D3000I Advantage Drive System, 230v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Recall Number Z-0917-2013
Classification Class III
Code Info Model #D3000I
Product Distributed Qty 23 units
Reason For Recall The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.

Event Detail

Event Id 64367
Product Type Devices
Status Ongoing
Recalling Firm Linvatec Corp. dba ConMed Linvatec
City Largo
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-24
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: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore