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U.S. Department of Health and Human Services

Class 2 Device Recall TransFx

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  Class 2 Device Recall TransFx see related information
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/
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
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.