Device recall

Z-1458-2022: Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816…

FDA device recall · Class II · Paragon 28, Inc.

Key facts

Recall number (Z-number) Z-1458-2022
Recall event 90478
Product Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Product code HRS
Recalling firm Paragon 28, Inc.
Recall class Class II
Status Open, Classified
FEI number 3008650117

At a glance

  • None 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)