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U.S. Department of Health and Human Services

Class 3 Device Recall RF MultiGen, 0406900000; Refurb RF MultiGen, 0406900000U

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  Class 3 Device Recall RF MultiGen, 0406900000; Refurb RF MultiGen, 0406900000U see related information
Date Initiated by Firm October 11, 2016
Date Posted November 16, 2016
Recall Status1 Terminated 3 on July 25, 2017
Recall Number Z-0584-2017
Recall Event ID 75485
510(K)Number K071482  
Product Classification Generator, lesion, radiofrequency - Product Code GXD
Product RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
Code Information RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kelly Jo Davis
269-389-2921
Manufacturer 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 2		 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 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 .
Quantity in Commerce 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:
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXD and Original Applicant = SYNERGETICS, INC
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