Device recall

Z-2535-2016: Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number…

FDA device recall · Class II · Straumann Manufacturing, Inc.

Key facts

Recall number (Z-number) Z-2535-2016
Recall event 74799
Product Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
Product code DZE
Recalling firm Straumann Manufacturing, Inc.
Recall class Class II
Status Terminated
Termination date Nov 20, 2020
510(k) numbers K150938
FEI number 1000121052

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)