Device recall

Z-2549-2025: Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray…

FDA device recall · Class II · Encore Medical, LP

Key facts

Recall number (Z-number) Z-2549-2025
Recall event 97412
Product Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder…
Product code FSM
Recalling firm Encore Medical, LP
Recall class Class II
Status Open, Classified
510(k) numbers K233481
FEI number 1000116912

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)