Class 2 Device Recall Zimmer TiTLE2 Polyaxial Spinal System

• Date Initiated by Firm: October 21, 2010
• Date Posted: January 10, 2011
• Recall Status: Terminated on October 12, 2011
• Recall Number: Z-0887-2011
• Recall Event ID: 57338
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.
• Code Information: L75118
• Recalling Firm/ Manufacturer: Zimmer Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: There is a chance that the ball plunger could fall out during surgery and fall into the surgical site. There could be a delay in surgery to remove the ball plunger. If the problem was undetected, the ball plunger could remain in the patient causing pain and potentially necessitating subsequent surgery for removal.
• FDA Determined Cause: Other
• Action: Zimmer sent an URGENT MEDICAL DEVICE RECALL LETTER dated October 21, 2010, to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to: Inspect their inventory, stop using the device, and place it in quarantine. Contact Zimmer Customer Service at 1-800-774-6368 to obtain a return authorization number. Complete the Inventory Return Certification form and fax a copy to (952) 837-6958, or scan and email to qualitycompliance@zimmer.com. Return the recalled product along with the original completed Return Certification Form to: Zimmer Spine, Inc. Attn: RA Receiving 5301 Riata Park Ct. Austin, Texas 78727 For questions regarding this recall call Zimmer Spine Customer Service at 1-866-774-6368. .
• Quantity in Commerce: 68
• Distribution: Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI.
• 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.