Class 2 Device Recall Zimmer Patient Helper Reinforced Overhead Bar

• Date Initiated by Firm: July 07, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on November 12, 2009
• Recall Number: Z-2297-2008
• Recall Event ID: 48714
• Product Classification: Patient Helper Reinforced Overhead Bar - Product Code IKX
• Product: Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed. IN; Prod. Nos. 00-2700-965-02 and 00-0965-001-00.
• Code Information: All units shipped between 7/11/07 and 5/19/08.
• FEI Number: 1000220733
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-321-5533
• Manufacturer Reason for Recall: If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the patient in the bed, and the drop could present a laceration hazard by creating a sharp edge on the metal bar.
• FDA Determined Cause: Device Design
• Action: Consignees were notified via recall letter dated 7/7/08 to discontinue use of these devices until the firm visits and replaces the devices. Contact Zimmer at 1-800-321-5533 for assistance.
• Quantity in Commerce: 645 of all systems
• Distribution: Nationwide and 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.