Date Initiated by Firm |
February 10, 2003 |
Date Posted |
June 05, 2003 |
Recall Status1 |
Terminated 3 on October 09, 2003 |
Recall Number |
Z-0907-03 |
Recall Event ID |
26320 |
510(K)Number |
K990848
|
Product Classification |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite - Product Code LXT
|
Product |
TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread. |
Code Information |
Catalog No./Part No./Ref.No. -- 00-4453-34-08. Lot Number: 70209800 |
Recalling Firm/ Manufacturer |
Immedica Inc 100 Passaic Ave. Chatham NJ 07928
|
For Additional Information Contact |
Forrest Rudnick 973-635-9040 Ext. 115
|
Manufacturer Reason for Recall |
Mislabeled; wrong identification number on pin.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letter was sent on 2/10/2003 to Zimmer Patient Care Division. The letter states that Zimmer is to conduct a sub-recall to their customers to account for the 127 pieces sent to them. |
Quantity in Commerce |
127 |
Distribution |
The product is only distributed to Zimmers Patient Care Division, P.O. Box 569, Dover, OH 44622. There are no government accounts. |
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.
|
510(K) Database |
510(K)s with Product Code = LXT and Original Applicant = IMMEDICA, INC.
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