Class 3 Device Recall Triton MP1 Traction Unit

• Date Initiated by Firm: May 30, 2003
• Date Posted: September 11, 2003
• Recall Status: Terminated on May 07, 2004
• Recall Number: Z-1215-03
• Recall Event ID: 26920
• 510(K)Number: K801643
• Product Classification: Table, Mechanical - Product Code INW
• Product: Triton MP-1 Traction Unit
• Code Information: Model/Catalogue Nos.: 7961 (120 Volt) and 7963 (220 Volt); Serial Numbers: 4231 - 4246, 6806 - 6809, 6815, 6818 ¿ 6819, 6824, 6851, 6856 ¿ 6859, 6863, 6870 ¿ 6873, 6878 ¿ 6919, 6921 ¿ 6958
• FEI Number: 1000342033
• Recalling Firm/ Manufacturer: Chattanooga Corp.; 4717 Adams Rd; Hixson TN 373434001
• For Additional Information Contact: Ms. Cheryl Bagwell; 423-870-7207
• Manufacturer Reason for Recall: Product contains an improper bracket for the transducer.
• FDA Determined Cause: Other
• Action: Recall notification was initiated by telephone on 05/30/2003 to the domestic accounts and via email to the foreign accounts.
• Quantity in Commerce: 96
• Distribution: Nationwide. TX, CO, MD, VA, FL, PA, NJ, NY, IN, OH, MI, MO, AL, NV, IL, CA, NM, AR, LA, NE, WA, NC, A, NH, and OK
• 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 = INW