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Recall Observatory FDA recall evidence

Device product

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

Z-0584-2017

October 11, 2016

Class III

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 75485
Status
Terminated
Classification
Class III
Quantity
2,675
Official record key
device-enforcement:Z-0584-2017

Official wording

Reason: 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.

Code information: RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U

Distribution pattern: 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:

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.