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Recall Observatory FDA recall evidence

Device 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

Z-0917-2013

January 24, 2013

Class III

Product summary

Firm
Linvatec Corp. dba ConMed Linvatec
Event
Event 64367
Status
Terminated
Classification
Class III
Quantity
23 units
Official record key
device-enforcement:Z-0917-2013

Official wording

Reason: 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.

Code information: Model #D3000I

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.