LowClass IIITerminated

FDA Devices recall · Reported March 13, 2013

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 13, 2013. Severity: Low. Recall number: Z-0916-2013.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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…

Recall #: Z-0916-2013
Affected scope: 31 units
Initiated: January 24, 2013

Compiled from official public sources by the publisher. · Updated September 2026

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Linvatec Corp. dba ConMed Linvatec recalled D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems functi… - a low-severity action.

D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems functi… was recalled by Linvatec Corp. dba ConMed Linvatec in March 13, 2013. Reason: The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on bot…. Check the official notice for the remedy. Verify recall #Z-0916-2013 with the FDA Devices before acting.

The recall

Linvatec Corp. dba ConMed Linvatec issued this low-severity FDA Devices recall-The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on bot….

Low
severity level: 31 units
affected scope: Class III
classification: March 13, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0916-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	Z-0916-2013
Date reported	March 13, 2013
Date initiated	January 24, 2013
Recalling firm	Linvatec Corp. dba ConMed Linvatec
Firm location	Largo, FL
Affected scope	31 units
Distribution	Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

31 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0916-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 13, 2013. Severity: Low. Recall number: Z-0916-2013.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Low), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported March 13, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026