Class 2 Device Recall Zimmer ITST

• Date Initiated by Firm: June 05, 2009
• Date Posted: August 04, 2009
• Recall Status: Terminated on December 22, 2009
• Recall Number: Z-1702-2009
• Recall Event ID: 52226
• 510(K)Number: K032367
• Product Classification: orthopedic surgical instrument - Product Code HSB
• Product: Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).
• Code Information: Lots 60639048 and 60657449.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-371-8603
• Manufacturer Reason for Recall: Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
• FDA Determined Cause: Process control
• Action: Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.
• Quantity in Commerce: 120 of both products
• Distribution: Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
• 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