Recall Z-0584-2017
Stryker Instruments Div. of Stryker Corporation · initiated October 11, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U
Codes / lots: 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.
FDA-determined 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 .
Details
- Recall number
- Z-0584-2017
- Initiated
- October 11, 2016
- Posted by FDA
- November 16, 2016
- Terminated
- July 25, 2017
- Product code
- GXD – Generator, Lesion, Radiofrequency
- Quantity
- 2,675
- 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:
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI