Encore Medical, LP: Medical Device Recall in 2020 - (Recall #: Z-1929-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 22, 2019

Date Posted: May 20, 2020

Recall Number: Z-1929-2020

Event ID: 85376

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 86 units

Code Information:

All lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated