| Class 2 Device Recall |  |
Date Initiated by Firm | January 06, 2003 |
Date Posted | January 23, 2003 |
Recall Status1 |
Terminated 3 on December 04, 2003 |
Recall Number | Z-0459-03 |
Recall Event ID |
25257 |
Product Classification |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
|
Product | Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on Co-Cr 12/14 tapers . Cat. No. 6418-26-02. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E. Main St. Warsaw IN 46580
|
For Additional Information Contact | 574-267-6131 |
Manufacturer Reason for Recall | Compression test results are not in accordance with device approval submission |
FDA Determined Cause 2 | Other |
Action | Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer. |
Distribution | United States. |
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.
|
|
|
|