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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.

FDA Recall Z-1786-2013 · Posted 2013-07-22

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeHST
Date Initiated2013-05-20
Date Terminated2013-08-28
Product Quantity16 units

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

Firm Action

STERIS Account Managers notified affected customers via onsite visits. All consignees were notified as of 5/29/2013. Customers were instructed to return affected product for a replacement unit.

Root Cause

Component change control

Distribution Pattern

USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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