Z-0916-2013 Class III Terminated
FDA device recall Z-0916-2013 was initiated by Linvatec Corp. dba ConMed Linvatec on January 24, 2013 and is designated Class III. Reason for recall: 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 … The recall status is terminated (terminated July 5, 2013). Affected quantity: 31 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2013
- Initiation Date
- January 24, 2013
- Termination Date
- July 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 units
Product Description
D3000 Advantage Drive System, 115v 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
Reason for Recall
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.
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
Code Information
Model #D3000