Class 2 Device Recall ConMed Linvatec Surgical Video Cart

• Date Initiated by Firm: October 31, 2007
• Date Posted: September 21, 2008
• Recall Status: Terminated on September 22, 2008
• Recall Number: Z-2458-2008
• Recall Event ID: 48195
• Product Classification: Surgical camera and accessories - Product Code KQM
• Product: ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500
• Code Information: Catalog Number: VP8500; Serial #;s: 6080185, 6080285, 6080385, 6080485, 6080585, 6080685, 6080785, 6080885, 6080985, 6081085, 6081185, 6081285, 6081385, 6081485, 6081585, 6081685, 6081785, 6081885, 6081985, 6082085, 6082185, 6082285, 6082385, 6082485, 6082585, 6082685, 6082785, 6082885, 6082985, 6083085, 6083185, 6083285, 6083385, 6083485, 6083585, 6083685, 6083785, 6083885, 6083985, 6084085, 6090185, 6090285, 6090385, 6090485, and 6090585.
• FEI Number: 1000125338
• Recalling Firm/ Manufacturer: Conmed Linvatec Endoscopy Division; 7416 Hollister Ave; Goleta CA 93117-2583
• For Additional Information Contact: Roger Murphy; 805-571-8135
• Manufacturer Reason for Recall: The recall was initiated because ConMed Linvatec has determined there is a possibility the wheel caster(s) may become loose which may result in the wheel caster(s) falling out of the base of the VP8500 Video Cart. The potential for the wheel caster or casters to fall out of the base of the cart may result in a potential tip hazard.
• FDA Determined Cause: Device Design
• Action: The recall was initiated by the firm sending the recall information packet via UPS overnight delivery to the Distribution and Sales Force in May 2008. The packet included: 1. Recall Notification and reply form for each consignee. 2. Instructions on the procedure to conduct the recall of the VP8500. 3. A list of affected consignees in their territory. The Recall Notification informed the customers of the potential for the wheel caster(s) to fall out of the base of the cart which may result in a potential tip hazard. The customers were instructed to discontinue the use of the VP8500 Video Cart immediately if the wheel caster(s) show any signs of being loose and to complete the recall reply form. Upon receipt of notification, distributors are supposed to : 1. Visit the affected accounts and provide them with a copy of the Recall Notification to inform them of the recall and the Recall Acknowledgment Reply Form which is to be mailed or faxed back to the firm. 2. Schedule the delivery and installation of refurbished carts to replace the recalled cart(s) by contacting Jill Cover, ConMed Linvatec Endoscopy Division at (888) 292-0100, ext. 8157 or e-mail jcover@livatec.com to arrange for replacement. 3. Move medical devices, etc. from the recalled cart(s) and set up the refurbished cart(s) with the required equipment at the account's location. (ProMEDICA will arrange for shipping of the recalled cart(s) back to ProMEDICA.)
• Quantity in Commerce: 45 Units Worlwide (42 in US)
• Distribution: Worldwide Distribution including states of: AK, AZ, CA, FL, GA, IL, IN, KS, MD, NC, NY, OH, and PA and country of Canada.
• 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.