FDAFDA · Food and drugs·Recall number Z-1665-2015
Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Published June 3, 2015 · Recall initiated: April 13, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- United Surgical Associates
- Distributor
- Domestic: HI International; None
- Lot
- Product #: i-95103 Elastic Knee Support SM Lot#: AP20140815001 Product#: i-95105 Elastic Knee Support MD Lot#: AP20140815001 Product #: i-95107 Elastic Knee Support LG Lot# AP20140815001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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