Class 2 Device Recall Zimmer Trabecular

• Date Initiated by Firm: October 19, 2006
• Date Posted: November 22, 2006
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-0210-2007
• Recall Event ID: 36657
• Product Classification: shoulder prosthesis instrumentation - Product Code HWT
• Product: Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.
• Code Information: Lots 60457716 and 60492624.
• 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 instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.
• FDA Determined Cause: Other
• Action: The firm''s sales force was notified via recall letter dated 10/19/06 to secure product from customer accounts and to return it to Zimmer.
• Quantity in Commerce: 50
• Distribution: Nationwide and Australia.
• 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.