Home / Recalls / United Surgical Associates / Z-1664-2015

Z-1664-2015 Class II Terminated

Recalled by United Surgical Associates — Fort Wayne, IN

Recall Details

Product Type
Devices
Report Date
June 3, 2015
Initiation Date
April 13, 2015
Termination Date
July 14, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1278

Product Description

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.

Reason for Recall

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

Distribution Pattern

Domestic: HI International; None

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

Other recalls by United Surgical Associates

  • Z-1666-2015 Class II — Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is (April 13, 2015)
  • Z-1665-2015 Class II — Elastic Knee Support. A limb orthosis (brace) is a device intended for medica (April 13, 2015)