Z-0584-2017Class III

RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U

Name: Z-0584-2017 RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-10-11
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-10-11 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U on 2016-10-11. FDA classified it as Class III and gives the reason as "Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained instructions...". 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-0584-2017
Classification: Class III
Status: Terminated
Initiated: 2016-10-11
Posted: 2016-11-16
Terminated: 2017-07-25
Recalling firm: Stryker Corp.
Product: RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U
Product code: GXD Generator, Lesion, Radiofrequency
Reason for recall: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen cables.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Stryker Instruments initiated a voluntary recall of the RF MultiGen, and Refurb RF MultiGen because the instructions for use contained incorrect instructions on sterilizing the device. Stryker distributed customer notices via certified mail on 10/11/2016. Customer's were instructed to do the following: Immediately review this recall notification. 2. Enclosed was a revised version of the IVS Care Instructions. Please distribute the revised version to the appropriate person or department. 3. Remove and discard any previously distributed IVS Care Instructions or Instructions for Use. 4. Please complete, sign, and return the enclosed Business Reply Form (BRF) acknowledging your receipt and understanding of this notification. 5. Fax the completed BRF to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to [email protected]. Customers with questions can contact: 269 323 7700 .
Quantity in commerce: 2,675
Distribution: Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden VA/DOD:
Product codes and lots: RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0584-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0584-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

Product code GXD

K071482Class IIStryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc. / cleared 2007-12-20

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)