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Class 2 Device Recall STERIS Fine Traction Device |
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Date Initiated by Firm |
May 20, 2013 |
Date Posted |
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
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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.
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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/ Manufacturer |
Steris Corporation 5960 Heisley Rd Mentor OH 44060-1834
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For Additional Information Contact |
440-392-7601
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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
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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
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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.
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