Class 2 Device Recall Trabecular Metal

• Date Initiated by Firm: June 28, 2013
• Date Posted: August 12, 2013
• Recall Status: Terminated on March 02, 2015
• Recall Number: Z-1954-2013
• Recall Event ID: 65502
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1; ; Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.
• Code Information: 60720060 60729529 60782351 60875299 60902349 60948238 60943023 60985367 61019824 61034822 61063216 61145917 61183670 61207699 61218854 61356595 61400936 61515555 61566478 61615548 61756075 61780197 61832594 61864229 61923988 61978214 62041752 62136099 62180444 62226761 and 62289420
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.
• FDA Determined Cause: Device Design
• Action: Zimmer Inc sent Urgent Medical Device Recall notifications on June 28, 2013, to all affected customers. The initial letter identified the issue, possible adverse consequences and informed customers that a replacement would be available in the coming months. In addition, the letter included references to both the TM Reverse Surgical Technique and to the video available on Zimmer TV and Zimmer.com. Both resources explain in detail the proper technique for utilization of the Glenosphere Helmet. Proper utilization of the Glenosphere Helmet dramatically reduces the likelihood of fracture. Distributors will receive a copy of the surgeon letter for their reference along with the list of affected surgeons. The affected surgeons will be identified using invoice data and in cases where the surgeon is unknown, the distributor will be instructed to assist with the surgeon list. In addition, information regarding the return process for the damaged devices will be included. Questions and concerns are directed to Zimmer's customer call center (1-877-946-2761). Phase 2: As replacement devices with the new design became available for distribution, a 2nd letter was sent to the distributors. Estimated replacement device availability will begin in July 2013. The distributors will be instructed to order replacement devices as a means of completing the affected instrument cases in circulation within their territories. Instructions for the return of devices were included. For questions regarding this recall call 800-613-6131.
• Quantity in Commerce: 3,163 both sizes
• Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Utd.Arab.Emir.
• 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.