RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U
This recall has been terminated (originally issued November 16, 2016).
- Recall Initiated
- October 11, 2016
- Posted
- November 16, 2016
- Terminated
- July 25, 2017
- Recall Number
- Z-0584-2017
- Quantity
- 2,675
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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
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:
Lot / Code Info
RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U
Root Cause
Labeling Change Control
Action Taken
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 .