D3000I Advantage Drive System — Class III medical device recall Z-0917-2013
Terminated recall by Linvatec Corp. dba ConMed Linvatec, reported 2013-03-13, distributed nationwide. The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both
| Recall number | Z-0917-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Linvatec Corp. dba ConMed Linvatec, Largo, FL, United States |
| Recall initiated | 2013-01-24 |
| Classified | 2013-03-06 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, ES, FR, RO, SE, SG, ZA |
| Quantity | 23 units |
| Model numbers | D3000I |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0917-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.