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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer ZMR

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  Class 2 Device Recall Zimmer ZMR see related information
Date Initiated by Firm August 02, 2006
Date Posted August 31, 2006
Recall Status1 Terminated 3 on May 04, 2007
Recall Number Z-1479-06
Recall Event ID 35943
510(K)Number K994286  
Product Classification hip prosthesis - Product Code LPH
Product Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-45 (Cat. no. 00999601945).
Code Information Lot 60451050.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Connie Morgan
Manufacturer Reason
for Recall
Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
FDA Determined
Cause 2
Action Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.
Quantity in Commerce 181 of all devices
Distribution Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.
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 = ZIMMER, INC.