Class 2 Device Recall Zimmer TM400 Broach Handle

• Date Initiated by Firm: April 29, 2009
• Date Posted: July 07, 2009
• Recall Status: Terminated on October 08, 2010
• Recall Number: Z-1246-2009
• Recall Event ID: 51675
• Product Classification: Broach Handle - Product Code HTQ
• Product: Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery. The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 952-857-5846
• Manufacturer Reason for Recall: The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device.
• FDA Determined Cause: Device Design
• Action: Distributors and user accounts were notified by "Urgent: Medical Device Recall" letter dated April 29, 2009. The letter described the affected product, reason for recall, health risks, and action for consignees. Distributors were instructed to retrieve the devices and to return them to Zimmer no later than May 13, 2009. This instrument recall will result in an inability to implant the associated devices until a new instrument becomes available. For questions or assistance about the recall please contact Zimmer Spine by calling 800-777-7505.
• Quantity in Commerce: 435
• Distribution: Nationwide, Austria, Australia, Belgium, Canada, Finland, Germany, Greece, Korea, South Africa, Sweden, Switzerland, Taiwan and the United Kingdom.
• 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.