—#150479

Product

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

FDA product code: GXD — Generator, Lesion, Radiofrequency
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K071482
Affected lot / code info: RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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 kellyjo.davis@stryker.com. Customers with questions can contact: 269 323 7700 .

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

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:

Timeline

Recall initiated: 2016-10-11
Posted by FDA: 2016-11-16
Terminated: 2017-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150479. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.