Sep

2005

Sammons Preston Rolyan – Class III

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Sammons Preston Rolyan – Class III

Amy Sellers

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