Reported Jul 31, 2013 · Terminated
STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- STERIS Fine Traction Device
- one unit per box Product UsageThe Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures
- Lot codes and dates
- The following serial/lot
- numbers are affected by this recall
040491315004049131510404913152040491315304087130010408713002040871300304087130040408713005040871300604098130970409813098040981309904098131000410113001041011300204107130240410713025041071302604107130270410713028and 0410713029
- Amount recalled
- 16 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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