Device recall

Z-0922-2014: SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or…

FDA device recall · Class II · Highland Metals, Inc.

Key facts

Recall number (Z-number) Z-0922-2014
Recall event 67378
Product SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
Product code DZC
Recalling firm Highland Metals, Inc.
Recall class Class II
Status Terminated
Termination date Feb 4, 2014
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

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