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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 16 units Z-1786-2013
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