Recall Z-1444-05 ยท HST Apparatus, Traction, Non-Powered
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
| Date | Aug 31, 2005 (initiated Jul 13, 2005) |
| Status | Terminated |
| Reason | The traction device may malfunction, producing oscillation and a jerking motion. |
| 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 |
| Quantity | 208 units |
| Distribution | Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992545 | TM-300 TRACTION SYSTEM Ito Co., Ltd., Sep 1, 1999 |