Date Initiated by Firm | July 18, 2006 |
Date Posted | November 16, 2006 |
Recall Status1 |
Terminated 3 on December 13, 2007 |
Recall Number | Z-0192-2007 |
Recall Event ID |
36237 |
510(K)Number | K032052 |
Product Classification |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer - Product Code HRY
|
Product | UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10 |
Code Information |
26014: Lot number 0305.13.2814, 26016: Lot number 0305.13.2815, 26018: Lot number 0305.13.2816, 26020: Lot number 0305.13.2817 Serial Number: None |
Recalling Firm/ Manufacturer |
Plus Orthopedics USA 10188 Telesis Ct San Diego CA 92121-4779
|
For Additional Information Contact | Clint Corona 888-741-7587 Ext. 2513 |
Manufacturer Reason for Recall | The modified devices were distributed by Plus
Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special
510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003. |
FDA Determined Cause 2 | Other |
Action | The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA. |
Quantity in Commerce | 12 |
Distribution | California |
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 = HRY
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