[Recalled] 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
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Linvatec Corp. dba ConMed Linvatec |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0917-2013 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 24 January 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.