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Recall Observatory FDA recall evidence

Device product

Elastic Ankle 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.

Z-1664-2015

April 13, 2015

Class II

Product summary

Firm
United Surgical Associates
Event
Event 71256
Status
Terminated
Classification
Class II
Quantity
1278
Official record key
device-enforcement:Z-1664-2015

Official wording

Reason: The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

Code information: Product #: i-94103 Elastic Ankle Support SM Lot#: AP20140815001 Product #: i-94105 Elastic Ankle Support MD Lot#: AP20140815001 Product #: i-94107 Elastic Ankle Support LG Lot#: AP20140815001

Distribution pattern: Domestic: HI International; None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction