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U.S. Department of Health and Human Services

Class 3 Device Recall Performa TM300 Traction System

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  Class 3 Device Recall Performa TM300 Traction System see related information
Date Initiated by Firm July 13, 2005
Date Posted August 31, 2005
Recall Status1 Terminated 3 on January 09, 2008
Recall Number Z-1444-05
Recall Event ID 31492
510(K)Number K992545  
Product Classification Apparatus, Traction, Non-Powered - Product Code HST
Product TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan
Code Information Product No. A501-009, serial numbers 1000 through 1207
Recalling Firm/
Manufacturer		 Sammons Preston Rolyan, An Ability One Company
4 Sammons Ct
Bolingbrook IL 60440-4995
For Additional Information Contact Mr. Steve Armstrong
651-686-1769
Manufacturer Reason
for Recall		 The traction device may malfunction, producing oscillation and a jerking motion.
FDA Determined
Cause 2		 Other
Action Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.
Quantity in Commerce 208 units
Distribution Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia
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 = HST and Original Applicant = ITO CO., LTD.
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