Class 2 Device Recall Stryker EMS Stair PRO

• Date Initiated by Firm: October 31, 2011
• Date Posted: February 06, 2012
• Recall Status: Terminated on August 28, 2013
• Recall Number: Z-0943-2012
• Recall Event ID: 60422
• Product Classification: Stretcher, hand-carried - Product Code FPP
• Product: Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional , Stryker Medical, Portage, MI 49002. Intended to provide the patient greater comfort and a sense of security.
• Code Information: Model 6251 and 6252, The Foot Rest Kit (pN 6252-700-003) Order numbers 2065939, 1739631, 2066066, 2066803, and 2066941.
• Recalling Firm/ Manufacturer: Stryker Medical Division of Stryker Corporation; 3800 East Centre Ave.; Portage MI 49002
• For Additional Information Contact: 269-324-6609
• Manufacturer Reason for Recall: The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Stryker Medical spoke with all customers who received these shipments prior to 10/31/2011 requesting information on kits affected and recalled foot rest units installed. December 5, 2011 Urgent Medical Device Recall Letters, with instructions on how to to either install a new Foot Rest Kit ( enclosed ) or dispose of any kits that were not installed were sent to both customers who could have installed recalled foot rest units. Customers needing help or assistance with installation are asked to call Stryker Technical Support a 1-800-327-0770. Customers were to complete and return a postage paid postcard confirming receipt. Customers with questions or concerns are asked to contact Kristin Dudek at 269-389-6927 M-F m 8 a.m. - 5 p.m. (EST)
• Quantity in Commerce: 3 units
• Distribution: Nationwide Distribution -- MI & MA.
• 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.