—#119612

Product

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 product code: HST — Apparatus, Traction, Non-Powered
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: The following serial/lot numbers are affected by this recall: 0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029.

Why it was 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

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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

Timeline

Recall initiated: 2013-05-20
Posted by FDA: 2013-07-22
Terminated: 2013-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.