Class 2 Device Recall Triton T700 Traction Unit

• Date Initiated by Firm: May 30, 2003
• Date Posted: September 11, 2003
• Recall Status: Terminated on May 07, 2004
• Recall Number: Z-1210-03
• Recall Event ID: 26916
• 510(K)Number: K801643
• Product Classification: unknown device name - Product Code ITF
• Product: Triton T-700 Traction Unit,
• Code Information: Model/Catalogue Nos.: 7950 (120 Volt) and 7952 (220 Volt); Serial Numbers: 6211-6230, 1907 & 1920
• FEI Number: 1000342033
• Recalling Firm/ Manufacturer: Chattanooga Corp.; 4717 Adams Rd; Hixson TN 373434001
• For Additional Information Contact: Cheryl L. Bagwell; 423-870-7207
• Manufacturer Reason for Recall: Product contains an improper bracket for the transducer.
• FDA Determined Cause: Other
• Action: Notification of the manufacturing defect and recall was initiated by telephone on 05/30/2003 to the domestic accounts and via email to the foreign accounts.
• Quantity in Commerce: 18 units
• Distribution: IL, CA, TX, OH, FL, LA, WA, NC and DC

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 = ITF