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U.S. Department of Health and Human Services

Class 2 Device Recall STERIS Fine Traction Device

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  Class 2 Device Recall STERIS Fine Traction Device see related information
Date Initiated by Firm May 20, 2013
Date Posting Updated July 22, 2013
Recall Status1 Terminated 3 on August 28, 2013
Recall Number Z-1786-2013
Recall Event ID 65573
Product Classification Apparatus, traction, non-powered - Product Code HST
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.
Code Information 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.
Recalling Firm/
Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact
Manufacturer 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
FDA Determined
Cause 2
Component change control
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.
Quantity in Commerce 16 units
Distribution USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.