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
FDA Recall Z-0917-2013 · Posted 2013-03-06
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Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeGEY
Date Initiated2013-01-24
Date Terminated2013-07-05
Product Quantity23 units
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.
Firm Action
Linvatec Corp sent an "URGENT: Medical Device Recall Notification" letter dated January 24, 2013 to its customers after initial phone notifications. The letter describes the affected product, problem and actions to be taken. Customers were instructed to immediate check facility's inventory for the affected product, use the enclosed FedEx air-bill when returning the product, and complete and return to the Recall Reply Form. For questions contact your Customer Service department at 800-535-8536 or fax at 727-319-5701 or email [email protected].
Root Cause
Error in labeling
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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