Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0916-2013 — 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

U.S. FDA — Device Enforcement · United States · 2013-01-24 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0916-2013
Date of alert
2013-01-24
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Linvatec Corp. dba ConMed Linvatec
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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