Stryker Instruments Div. of Stryker Corporation recalls RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

Recall date

October 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0584-2017

FDA classification

Class III

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

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…

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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