Z-0916-2013Class III

D3000 Advantage Drive System, 115v

Name: Z-0916-2013 D3000 Advantage Drive System, 115v
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2013-01-24
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2013-01-24 / Terminated / root cause: labeling and UDI

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories... on 2013-01-24. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0916-2013
Classification: Class III
Status: Terminated
Initiated: 2013-01-24
Posted: 2013-03-06
Terminated: 2013-07-05
Recalling firm: Linvatec Corporation
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
Product code: GEY Motor, Surgical Instrument, Ac-Powered
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Linvatec Corp sent an "URGENT: Medical Device Recall Notification" letter dated January 24, 2013 to its customers after initial phone notifications. The letter describes the affected product, problem and actions to be taken. Customers were instructed to immediate check facility's inventory for the affected product, use the enclosed FedEx air-bill when returning the product, and complete and return to the Recall Reply Form. For questions contact your Customer Service department at 800-535-8536 or fax at 727-319-5701 or email [email protected].
Quantity in commerce: 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
Product codes and lots: Model #D3000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0916-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0916-2013	Class III	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-06
Z-0917-2013	Class III	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-06

Product code GEY

K050519Class IAdvanced Turbo Drive SystemLinvatec Corp. / cleared 2005-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)