Z-0584-2017 Class III Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-0584-2017 was initiated by Stryker Instruments Div. Of Stryker Corporation on Oct 11, 2016 and is designated Class III. 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… The recall status is terminated (terminated Jul 25, 2017). Affected quantity: 2,675.

Recall details

Product Type
Devices
Report Date
Nov 23, 2016
Initiation Date
Oct 11, 2016
Termination Date
Jul 25, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,675

Product description

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

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.

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:

Code information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0584-2017
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-0584-2017. Report a data issue: hello@regdatalab.com.