Recall Z-1786-2013— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2013-05-20, terminated 2013-08-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-20
- Terminated
- 2013-08-28
- Firm location
- Mentor, OH, United States
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.
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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