Class 2 Device Recall Stryker Vision Mounting Arm

• Date Initiated by Firm: August 30, 2013
• Date Posted: September 24, 2013
• Recall Status: Terminated on April 30, 2014
• Recall Number: Z-2271-2013
• Recall Event ID: 66211
• Product Classification: Cart, emergency, cardiopulmonary (excluding equipment) - Product Code BZN
• Product: Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.
• Code Information: Model number 0240-095-200, all serial numbers.
• Recalling Firm/ Manufacturer: Stryker Endoscopy; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: 800-624-4422 Ext. 3
• Manufacturer Reason for Recall: When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.
• FDA Determined Cause: Device Design
• Action: Stryker Endiscopy sent an Urgent Device Correction letter dated August 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inform individuals within their organization who needed to be aware of this Medical Device Field Correction, contact Stericycle at 1-877-546-0482 or email stryker4645@stericycle.com to schedule a time for Stericycle to perform the correction, or perform the correction themselves by requesting the materials and following the correction instructions included. Customers were also instructed to report all adverse events or product quality problems to Stryker Endoscopy at 1-800-624-4422, press 3 for Customer Service. --UPDATE-- On September 17, 2013, the recall was expanded to include additional customers who may have received the screw and washer included with the design change update. Notification was sent to these consignees on September 17, 2013. .
• Quantity in Commerce: 14271 units
• Distribution: Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and internationally to Australia, Canada, Chile, China, Argentina, Guam, Taiwan, India, Japan, Korea, Latin America, Philippines, Mexico, New Zealand, Hong Kong, Singapore, and Switzerland.
• 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.