Sammons Preston Rolyan, An Ability One Company 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Sammons Preston Rolyan, An Ability One Company
Lot Codes / Batch Numbers
Product No. A501-009, serial numbers 1000 through 1207
Products Sold
Product No. A501-009, serial numbers 1000 through 1207
Sammons Preston Rolyan, An Ability One Company is recalling TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sam due to The traction device may malfunction, producing oscillation and a jerking motion.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The traction device may malfunction, producing oscillation and a jerking motion.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026