FDA Medical Device Recalls (openFDA)
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 number
- Z-1444-05
- Recalling firm
- 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
- Status
- Terminated
- Initiated
- 2005-07-13
- Posted
- 2005-08-31
- Terminated
- 2008-01-09
- 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 the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.
- Quantity
- 208 units
- Distribution
- Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia
- Lot, serial or model codes
- Product No. A501-009, serial numbers 1000 through 1207
- 510(k) numbers
- ["K992545"]
- PMA numbers
- not on file
- Product code
- HST
- Firm FEI
- 1418324
- Firm city
- Bolingbrook
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28