Device recall

Z-1381-2020: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference…

FDA device recall · Class II · Biomet 3i, LLC

Key facts

Recall number (Z-number) Z-1381-2020
Recall event 84771
Product CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
Product code NHA
Recalling firm Biomet 3i, LLC
Recall class Class II
Status Terminated
Termination date Aug 2, 2021
510(k) numbers K072642
FEI number 1038806

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)