PlainRecalls
FDA Devices Moderate Class II Terminated

STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.

Reported: July 31, 2013 Initiated: May 20, 2013 #Z-1786-2013

Product Description

STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.

Reason for Recall

A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluati

Details

Recalling Firm
Steris Corporation
Units Affected
16 units
Distribution
USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
Location
Mentor, OH

Frequently Asked Questions

What product was recalled?
STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.. Recalled by Steris Corporation. Units affected: 16 units.
Why was this product recalled?
A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluati
Which agency issued this recall?
This recall was issued by the FDA Devices on July 31, 2013. Severity: Moderate. Recall number: Z-1786-2013.