Class 2 Device Recall Stryker Eye Surgery Stretcher 1069

• Date Initiated by Firm: February 26, 2010
• Date Posted: September 01, 2010
• Recall Status: Terminated on April 21, 2011
• Recall Number: Z-2341-2010
• Recall Event ID: 54265
• Product Classification: Bed, Manual - Product Code FNJ
• Product: Eye surgery stretcher with crank fowler, model 1069 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: A stretcher used for eye surgery.
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• Recalling Firm/ Manufacturer: Stryker Medical Div. of Stryker Corporation; 3800 E. Centre Ave.; Portage MI 49002
• For Additional Information Contact: Jeff Masten; 269-324-6609
• Manufacturer Reason for Recall: The fowler of the bed is raised by a crank. The crank cosnsists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inopperable over time with excessive wear of the brass nut.
• FDA Determined Cause: Device Design
• Action: The firm, Stryker Medical, sent an "Urgent Medical Device Correction" letter dated February 26, 2010, to all customers. The letter describes the product, problem and action to be taken by customers. The letter states that Stryker field service tech will contact the firm and perform device corrections within four months. The customers were instructed to locate the recalled stretchers and verify that there is no grinding noise when activating the fowler. If the fowler exhibited a grinding noise, the customers were instructed to remove the stretcher from service and contact the recalling firm at 800-STRYKER, option 3. Note: Do not put the stretcher back into service until it is repaired by our field service representative. The customers were also instructed to return the enclosed post card to confirm receipt of this notice; inform any new users and advise the firm of new locations if any of the listed stretchers were on loan or sold, and advise the firm of the obsolescence by providing the serial numbers if any of the listed stretchers were disposed of. If you have any urgent questions or concerns, contact (269) 324-6884. Normal hours are Monday-Friday 8am-5pm(EST).
• Quantity in Commerce: 911
• Distribution: Worldwide distribution: USA and countries including Australia, Canada, Chile, China, France, Germany, Greece, Spain, Italy, Japan, South Africa, Taiwan, Korea, Singapore, and UK.
• 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.