Device product
RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
Z-0584-2017
Product summary
- 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
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.