Recall Z-0917-2013— Linvatec Corp. dba ConMed Linvatec
Class III · Terminated
Class III FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2013-01-24, terminated 2013-07-05. It names one FDA 510(k) clearance: K050519. 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. 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..
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-01-24
- Terminated
- 2013-07-05
- Firm location
- Largo, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.