Class 2 Device Recall Zimmer Natural Nail System, Tibial Targeting Guide Handle

• Date Initiated by Firm: July 01, 2009
• Date Posted: November 24, 2009
• Recall Status: Terminated on October 05, 2011
• Recall Number: Z-0378-2010
• Recall Event ID: 52806
• 510(K)Number: K082770 K083497 K090596
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
• Code Information: Lots 61161115, 61170213, 61219945, 61256543, 61233590 and 61256542.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
• FDA Determined Cause: Other
• Action: On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
• Quantity in Commerce: 327 of total product
• Distribution: Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and 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.

• 510(K) Database: 510(K)s with Product Code = HSB