Class 2 Device Recall Zimmer MIS

• Date Initiated by Firm: February 02, 2006
• Date Posted: March 21, 2006
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-0672-06
• Recall Event ID: 34634
• Product Classification: Orthopedic Manual Surgical Instrument - Product Code LXH
• Product: Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
• Code Information: Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
• FDA Determined Cause: Other
• Action: Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products.
• Quantity in Commerce: 495 Right and Left
• Distribution: Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
• 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.