Device recall

Z-1821-2024: APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with…

FDA device recall · Class II · Medartis Inc.

Key facts

Recall number (Z-number) Z-1821-2024
Recall event 94445
Product APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Product code HWC
Recalling firm Medartis Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K091479
FEI number 3009540749

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)