Date Initiated by Firm | November 13, 2006 |
Date Posted | December 08, 2007 |
Recall Status1 |
Terminated 3 on December 13, 2007 |
Recall Number | Z-0361-2008 |
Recall Event ID |
45480 |
510(K)Number | K022204 |
Product Classification |
Tibia Insert - Product Code JWH
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Product | VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121 |
Code Information |
Model Number: 0214612, Lot Number: 044159 No serial numbers |
Recalling Firm/ Manufacturer |
Plus Orthopedics USA 10188 Telesis Ct San Diego CA 92121-4779
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For Additional Information Contact | Clint Corona 888-741-7587 Ext. 2511 |
Manufacturer Reason for Recall | Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert. |
FDA Determined Cause 2 | Employee error |
Action | Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices. |
Quantity in Commerce | 10 |
Distribution | Nationwide: USA including states of ID, NY, VA & WI |
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 = JWH
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