Device recall

Z-1011-2022: Smart Toe II Intramedullary Arthrodesis Implant

FDA device recall · Class II · Stryker GmbH

Key facts

Recall number (Z-number) Z-1011-2022
Recall event 89861
Product Smart Toe II Intramedullary Arthrodesis Implant
Product code HTY
Recalling firm Stryker GmbH
Recall class Class II
Status Open, Classified
510(k) numbers K112197
FEI number 3002807830

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)