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Class 2 Device Recall MOST, Sulzer Orthopedics |
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| 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.
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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 and Original Applicant = SULZER ORTHOPEDICS, INC.
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