Class 2 Device Recall Stryker Evacuation Chair

• Date Initiated by Firm: June 28, 2011
• Date Posted: August 11, 2011
• Recall Status: Terminated on August 29, 2013
• Recall Number: Z-3010-2011
• Recall Event ID: 59112
• Product Classification: Stretcher, hand-carried - Product Code FPP
• Product: Stryker Evacuation Chair Model 6254; ; It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.
• Code Information: Model 6254, Lot numbers 110143822, 110143823, 110143824, 110143825, 110143826, 110143827, 101240120, 101240121, 101240122, 110142843, 110143758, 101240123, 101240124, 101240125, 101240126, 101240441, 101240442, 101240443, 101240863, 110142646, 110142632, 110142619, 110143756, 101240880, 110143801, 101240850, 101240851, 101240852, 101240853, 101240854, 101240855, 110143828, 110143829, 110143830, 110143831, 101241171, 101240127, 101240128, 101240129, 101240130, 101240131, 101240868, 101240892, 101240893, 101240894, 101240895, 101240896, 101240897, 101240898, 101240119, 110142620, 110143282, 110143283, 110143284, 110143281, 101240132, 101240133, 101240134, 101240135, 101240136, 101240137, 101240138, 101240139, 101240140, 101240141, 101240142, 101240143, 101240144, 101240858, 101240859, 101240860, 101240861, 101240862, 110143753, 110143754, 110143755, 101239046, 101239047, 101239048, 110142616, 110142617, 110142618, 101240145, 101240146, 110142625, 101241172, 101241173, 101241174, 101241175, 101241176, 101241177, 110142624, 101240870, 110142652, 110142653, 110142648, 110142649, 110142650, 110142651, 101241444, 101241445, 101241446, 101241447, 101241448, 101241449, 101240437, 101240438, 101240439, 101240440, 101241863, 101241864, 101241865, 101241866, 101240864, 101240865, 101240866, 101240867, 110142647, 110143222, 110142633, 110142634, 110142844, 110142621, 101240100, 101240101, 101240102, 101240103, 101240104, 101240105, 101240106, 101240107, 101240108, 101240109, 101240110, 101240111, 101240112, 101240113, 101240114, 101240881, 101240882, 101240883, 101240884, 110143832, 110143835, 110143797, 110143798, 110143799, 110143800, 110143750, 110143751, 110143757, 101240869, 110143802, 110143803, 110143804, 110143793, 110143794, 110143795, 110142630, 110142631, 101239030, 101239031, 101239032, 101239033, 101239034, 101239035, 101239036, 101239037, 101239038, 101239039, 101239040, 101239041, 101239042, 101239043, 101239044, 101239045, 101240416, 101240417, 101240418, 101240419, 101240420, 101240421, 101240422, 101240423, 101240424, 101240425, 101240426, 101240427, 101240428, 101240429, 101240430; ; 01240431, 101240432, 101240433, 101240434, 101240435, 101241170, 101241152, 101240838, 101240839, 101240840, 101240841, 101240842, 101240843, 101240844, 101240845, 101240846, 101240408, 110143796, 101240118, 110142840, 110142841, 110142842, 101240409, 101240410, 101240411, 101240412, 101240413, 101240414 and 101240415.
• Recalling Firm/ Manufacturer: Stryker Medical Division of Stryker Corporation; 3800 East Centre Ave.; Portage MI 49002
• For Additional Information Contact: Stryker Customer Service; 800-787-9537
• Manufacturer Reason for Recall: Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to the degree that they permanently engage the track locking mechanism
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, Stryker Medical, sent an "Urgent-Medical Device Recall" letter dated June 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate the listed product; inspect each unit prior to use; return the enclosed post card to confirm receipt of this notification; if they have loaned or sold any of the chairs listed, forward a copy this letter to the new users and advise Stryker of new users names and locations, and if they have disposed of any of the affected chairs and they are no longer in use, advise Stryker of their obsolescence by providing them with the serial numbers. Stryker stated in the letter that, their goal is the timely upgrade of all affected units within the next 90 days. If you have any questions or concerns, please contact us at 800-STRYKER, option 2. Please reference RA-2011-027. Normal business hours are Monday-Friday 8am-5pm EST.
• Quantity in Commerce: 220
• Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
• 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.