FDA Device recall Z-0916-2013
D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpie…
- FDA Device
- Class III
- terminated
- Published 2013-03-13
On 2013-03-13 the FDA classified a Class III recall of D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpie… by Linvatec, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0916-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-01-24 |
| Published | 2013-03-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Linvatec |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Model #D3000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0916-2013%22
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