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 |
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