Class 2 Device Recall

• Date Initiated by Firm: February 22, 2006
• Date Posted: March 07, 2006
• Recall Status: Terminated on April 05, 2006
• Recall Number: Z-0597-06
• Recall Event ID: 34628
• 510(K)Number: K920955
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
• Product: Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3, Right; Ref 7356-02-103.
• Code Information: Lot 1648124.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer Reason for Recall: Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left.
• FDA Determined Cause: Other
• Action: Firm''s sales representatives were notified via email on 2/22/06 to visit the customers, remove the product from inventory, and to return it to the firm.
• Quantity in Commerce: 5
• Distribution: Arizona, Wisconsin 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.

• 510(K) Database: 510(K)s with Product Code = LPH and Original Applicant = INTERMEDICS ORTHOPEDICS