Company: Sammons Preston Rolyan
Date of Enforcement Report: 9/14/05
Class:III

PRODUCT
TM-300 Traction System; an Rx software driven device used for patient traction, Product No. A501-009, Recall # Z-1444-05

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

CODE
Serial numbers 1000 through 1207

RECALLING FIRM/MANUFACTURER
Recalling Firm: Sammons Preston Rolyan, Bolingbrook, IL, by letters dated July 13, 2005.
Manufacturer: ITO Co., Ltd, Inashiki-gun, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
208 units

DISTRIBUTION
Nationwide and Internationally