Device recall

Z-1604-2023: ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended…

FDA device recall · Class II · Hiossen Inc.

Key facts

Recall number (Z-number) Z-1604-2023
Recall event 92272
Product ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Product code DZE
Recalling firm Hiossen Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K151626
FEI number 3007135442

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)