Agency classClass IIIOur severity:Low FDA (Devices)·Z-0916-2013·Announced 2013-03-13

Linvatec Recalls D3000 Advantage Drive Systems Due to Incorrect Panel Symbology

Linvatec Corp. is recalling 31 D3000 Advantage Drive Systems because the front panel contains incorrect symbology, violating IEC60606-01 standards.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the defect is unlikely to cause adverse health consequences. The issue is limited to incorrect symbology on the panel, a documentation and labeling defect.

Plain-English summary

Linvatec Corp. dba ConMed Linvatec is recalling 31 units of the D3000 Advantage Drive System, 115v. This powered instrument system is used in medical settings to perform cutting of soft tissue and bone using handpieces and accessories.

The recall was initiated because the Membrane Switch Panel, also known as the front panel (component part number A34-003-207), contains incorrect symbology. This defect violates the third edition of IEC60606-01, which sets general requirements for basic safety and essential performance in medical electrical equipment.

The affected units were distributed worldwide, including nationwide in the United States and in Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden, and Singapore. Users of these devices should contact the manufacturer for instructions on how to resolve the labeling issue.

The recalled product

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
Manufacturer: Linvatec Corp. dba ConMed Linvatec
Category: Medical Device — Surgical Power Tools
Hazard: mis-labeling
Affected units: 31

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 #D3000

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Linvatec Corp. dba ConMed Linvatec

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Same hazard · mis labeling