EMPOWR Acetabular System recalled over sterility concerns

Recall date

October 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Encore Medical, LP recalls 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…

Recall number

Z-1929-2020

FDA classification

Class II

Brand / firm

Encore Medical, LP

Sold / distributed

US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.

Why it was recalled

The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts.