ConMed Linvatec Recalls D3000I Surgical Drive Systems Due to Incorrect Symbology
ConMed Linvatec is recalling 23 D3000I Advantage Drive Systems because the membrane switch panel contains incorrect symbology, violating IEC60606-01 standards.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a labeling/symbology error rather than a functional safety defect causing immediate harm.
Plain-English summary
Linvatec Corp. dba ConMed Linvatec is recalling 23 units of the D3000I Advantage Drive System, a 230v surgical instrument motor used for cutting soft tissue and bone. The recall is due to a defect in the Membrane Switch Panel (component part number A34-003-207), which contains incorrect symbology. This error violates the third edition of IEC60606-01 Medical Electrical Equipment standards regarding general requirements for basic safety and essential performance.
The affected units were distributed worldwide, including nationwide in the United States (specifically in CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX) and in Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden, and Singapore. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare facilities and users of the D3000I Advantage Drive System should stop using the affected units and contact the recalling firm for instructions on how to proceed. The incorrect symbology on the front panel may lead to confusion regarding the device's controls, although no specific injuries or illnesses have been reported in the source text.
The recalled product
- 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
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Hazard
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model #D3000I
Distribution
Part of a larger recall action
This product is one of 2 recalled by Linvatec Corp. dba ConMed Linvatec under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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