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U.S. Department of Health and Human Services

Class 2 Device Recall MOST, Sulzer Orthopedics

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  Class 2 Device Recall MOST, Sulzer Orthopedics see related information
Date Initiated by Firm December 17, 2004
Date Posted February 15, 2005
Recall Status1 Terminated 3 on November 27, 2007
Recall Number Z-0539-05
Recall Event ID 30720
510(K)Number K013031  
Product Classification Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer - Product Code KRO
Product MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
Code Information Catalog Numbers: 5000-50-100 and 5000-50-200; Lot Numbers: 1529444, 1536181, 1538936, 1538937, 1542189, 1568350, 1568351, 1569597, 1596886, 1596890, 1601839, 1601841, 1610470, 1616609, and 1617691
Recalling Firm/
Zimmer Austin, Inc
9900 Spectrum Dr
Austin TX 78717-4555
Manufacturer Reason
for Recall
Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
FDA Determined
Cause 2
Action The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product.
Quantity in Commerce 121 units
Distribution The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal
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 = KRO and Original Applicant = SULZER ORTHOPEDICS, INC.