Recall Z-0584-2017 ยท GXD Generator, Lesion, Radiofrequency
Stryker Instruments Div. of Stryker Corporation
RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U
| Date | Nov 16, 2016 (initiated Oct 11, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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 |
| 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, Argentin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 Synergetics, Inc., Dec 20, 2007 |