Device recall

Z-0281-2024: RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF…

FDA device recall · Class II · Encore Medical, LP

Key facts

Recall number (Z-number) Z-0281-2024
Recall event 93221
Product RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Product code KWS
Recalling firm Encore Medical, LP
Recall class Class II
Status Open, Classified
510(k) numbers K172351
FEI number 1000116912

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)