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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

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.
Recall Number Z-1786-2013
Classification Class II
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.
Product Distributed Qty 16 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 evaluation of a Fine Traction Device returned by a Customer it was determined that the original part, the bearing, was used in Fine Traction Devices distributed to Customers.

Event Detail

Event Id 65573
Product Type Devices
Status Ongoing
Recalling Firm Steris Corporation
City Mentor
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-20
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.