TM-300 Traction System…

Date posted by the FDA

Aug. 31, 2005

Status

Terminated

Filed by

Sammons Preston Rolyan, An Ability One Company

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

Reason

The traction device may malfunction, producing oscillation and a jerking motion.

Distribution pattern

Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia

Quantity

208 units

Codes and lots

Product No. A501-009, serial numbers 1000 through 1207

Recall started

July 13, 2005

Device type

Apparatus, Traction, Non-Powered

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-1444-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1444-05. The agency record governs; check it and the company before acting.