The FDA announced on 2019-10-22 that Encore Medical, LP is recalling the Non-Sterile EMPOWR Acetabular System due to fracturing impactor balls that could leave debris in the joint. The agency issued recall number Z-1929-2020 for the voluntary Class II action.
How to tell if you have it
- Brand: Encore Medical
- Product: EMPOWR Acetabular System, Non-Sterile
- Model Numbers: 803-15-023, 803-15-026, 803-15-027, 803-15-028, 803-15-029, 803-15-030
- Quantity: 86 units
The hazard
The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing or cracking during impaction, which could cause debris to migrate or be left in the joint space.
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since 2017-05-31. Recent brand recalls include an EMPOWR 3D Knee Ins product mix-up on 2026-02-16 and an RSP Humeral Socket Insert labeling hazard on 2026-01-15. Other recent recalls of similar products include Howmedica SCORPIO C-DOME/PATELLA Implants (2026-07-30), Howmedica OMNIFIT Series I Acetabular Insert (2026-07-30), and Howmedica SCORPIO Patella Implants (2026-07-30).