Device recall

Z-1418-2024: Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number…

FDA device recall · Class II · Exactech, Inc.

Key facts

Recall number (Z-number) Z-1418-2024
Recall event 94092
Product Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
Product code PHX
Recalling firm Exactech, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K063569
FEI number 1038671

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)