RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U
FDA Recall Z-0584-2017 · Posted 2016-11-16
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeGXD
Date Initiated2016-10-11
Date Terminated2017-07-25
Product Quantity2,675
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.
Firm 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 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 [email protected]. Customers with questions can contact: 269 323 7700 .
Root Cause
Labeling Change Control
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:
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.