Device recall

Z-1664-2015: Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical…

FDA device recall · Class II · United Surgical Associates

Key facts

Recall number (Z-number) Z-1664-2015
Recall event 71256
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.
Product code ITW
Recalling firm United Surgical Associates
Recall class Class II
Status Terminated
Termination date Jul 14, 2015
FEI number 3003707831

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)