Z-1444-05

TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons...

Name: Z-1444-05 TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons...
Creator: Sammons Preston Rolyan, An Ability One Company
Published: 2005-07-13
License: https://open.fda.gov/license/

Patterson Medical Holdings, Inc. / initiated 2005-07-13 / Terminated

FDA source

Sammons Preston Rolyan, An Ability One Company began a recall of TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook... on 2005-07-13. The reason FDA records is "The traction device may malfunction, producing oscillation and a jerking motion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1444-05
Status: Terminated
Initiated: 2005-07-13
Posted: 2005-08-31
Terminated: 2008-01-09
Recalling firm: Patterson Medical Holdings, Inc.
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
Product code: HST Apparatus, Traction, Non-Powered
Reason for recall: The traction device may malfunction, producing oscillation and a jerking motion.
FDA root cause: 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
Product codes and lots: Product No. A501-009, serial numbers 1000 through 1207

Product code HST

K992545Class IITm-300 Traction SystemIto Co., Ltd. / cleared 1999-09-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)