Class 2 Device Recall Sirus

• Date Initiated by Firm: September 30, 2005
• Date Posted: October 28, 2005
• Recall Status: Terminated on December 28, 2005
• Recall Number: Z-0091-06
• Recall Event ID: 33810
• Product Classification: Bit, Surgical - Product Code GFG
• Product: Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.
• Code Information: Lots 480103, 480104 and 487665.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: Connie Morgan; 574-372-4269
• Manufacturer Reason for Recall: The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
• FDA Determined Cause: Other
• Action: Consignees were notified via recall letter dated 9/30/05.
• Quantity in Commerce: 27
• Distribution: Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia.
• 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.