Device recall

Z-1478-2022: Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in…

FDA device recall · Class II · Stryker Instruments

Key facts

Recall number (Z-number) Z-1478-2022
Recall event 90535
Product Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Product code HBE
Recalling firm Stryker Instruments
Recall class Class II
Status Open, Classified
510(k) numbers K143320
FEI number 3015967359

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)