Class 2 Device Recall TransFx

• Date Initiated by Firm: February 10, 2003
• Date Posted: June 05, 2003
• Recall Status: Terminated 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: 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.