| Class 2 Device Recall MOST, Sulzer Orthopedics | |
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
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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/ Manufacturer |
Zimmer Austin, Inc 9900 Spectrum Dr Austin TX 78717-4555
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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 | Other |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = KRO
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