Device recall

Z-1164-2021: Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred…

FDA device recall · Class II · G & H Wire Company

Key facts

Recall number (Z-number) Z-1164-2021
Recall event 87248
Product Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three…
Product code ECI
Recalling firm G & H Wire Company
Recall class Class II
Status Terminated
Termination date Sep 20, 2021
FEI number 1833132

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)