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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 22, 2006
Date Posted March 07, 2006
Recall Status1 Terminated 3 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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left.
FDA Determined
Cause 2
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