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Class 3 Device Recall Triton MP1 Traction Unit |
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Date Initiated by Firm |
May 30, 2003 |
Date Posted |
September 11, 2003 |
Recall Status1 |
Terminated 3 on May 07, 2004 |
Recall Number |
Z-1215-03 |
Recall Event ID |
26920 |
510(K)Number |
K801643
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Product Classification |
Table, Mechanical - Product Code INW
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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 |
Recalling Firm/ Manufacturer |
Chattanooga Corp. 4717 Adams Rd Hixson TN 373434001
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For Additional Information Contact |
Ms. Cheryl Bagwell 423-870-7207
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Manufacturer Reason for Recall |
Product contains an improper bracket for the transducer.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = INW and Original Applicant = CHATTANOOGA GROUP, INC.
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