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U.S. Department of Health and Human Services

Class 2 Device Recall Linvatec Power Cord Reel Catalog Number:

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 Class 2 Device Recall Linvatec Power Cord Reel Catalog Number:see related information
Date Initiated by FirmFebruary 23, 2010
Date PostedJanuary 04, 2011
Recall Status1 Terminated 3 on March 22, 2012
Recall NumberZ-0847-2011
Recall Event ID 56829
Product Classification Camera, surgical and accessories - Product Code KQM
ProductThe Power Cord Reel is labeled as follows: REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.
Code Information Power Cord Assembly Self Retracting (Catalog Number: VP6547)  Lot Number: 1160 1533 1590 1959 2534 2558 2595 2724 2798 2905 3009 3269 3428 3831 3831 4099 4498 4894 5209 
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information ContactRoger Murphy
727-399-5205
Manufacturer Reason
for Recall		ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart Multi-Specialty 120 VAC (VP6502), (3.) Video Cart Articulating Arm 120V (VP6504), (4.) Video Cart (VP8500), and (5.) Power Cord Assembly Self Retracting (VP6547). These products are being recalled due to there is a possibility that the Vid
FDA Determined
Cause 2		Component design/selection
ActionConMed Linvatec sent URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters to their customers by FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review their plugs for damage and determine if they were affected. Distributors were asked to contact affected customers and schedule delivery of their replacement plugs within 30 days. If the account no longer has the product in their possession, or if they have transferred the product, they were asked to respond as such via a Reply form. Customers were asked to document delivery of replacement plugs on the Sales Rep Reply Form and mail back or return by fax to 1-888-370-3062. For questions regarding this recall call the Customer Service Department at 1-888-292-0100 or e-mail Custserv1@Invatec.com.
Quantity in Commerce77 ea
DistributionWorldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, South Africa, United Arab Emirates, and Venezuela.
Total Product Life CycleTPLC 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.
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