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Linvatec Corp. dba ConMed Linvatec recalls D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function
Recalled March 13, 2013 · FDA recall Z-0917-2013 · Linvatec Corp.
Hazard
The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, 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. · FDA Class III
Units
23 units
Sold at
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
Description
The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, 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.
Product
D3000I Advantage Drive System, 230v, surgical instrument motor. 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
Manufacturer(s)
Linvatec Corp. dba ConMed Linvatec
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →