Class 2 Device Recall Zimmer

• Date Initiated by Firm: June 28, 2007
• Date Posted: December 15, 2007
• Recall Status: Terminated on March 17, 2008
• Recall Number: Z-0316-2008
• Recall Event ID: 38468
• Product Classification: Offset Rasp Handle - Product Code LXH
• Product: Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
• Code Information: Lot No: 60646894.
• FEI Number: 1000220733
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E. Main St.; Warsaw IN 46580-2304
• For Additional Information Contact: 574-372-4269
• Manufacturer Reason for Recall: Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound
• FDA Determined Cause: Process control
• Action: Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer.
• Quantity in Commerce: 62 (total for Z-0316-0317-2008)
• Distribution: Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
• 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.