Device recall

Z-2148-2025: Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual…

FDA device recall · Class II · Encore Medical, LP

Key facts

Recall number (Z-number) Z-2148-2025
Recall event 97094
Product Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular system, 28mm femoral heads and all hip stems…
Product code LPH
Recalling firm Encore Medical, LP
Recall class Class II
Status Open, Classified
510(k) numbers K203557
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)