Class 2 Device Recall Trabecular Metal Shoulder Instrumentation

• Date Initiated by Firm: June 16, 2006
• Date Posted: July 27, 2006
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-1284-06
• Recall Event ID: 35783
• Product Classification: shoulder prosthesis instrument - Product Code HWT
• Product: Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 12 mm diameter, 170 mm length, non-sterile, catalog no. 4309-12-17 (00-4309-012-17).
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
• FDA Determined Cause: Other
• Action: U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.
• Quantity in Commerce: 324 total
• Distribution: Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.
• 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.