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.

Recall Initiated

October 22, 2019

Recall Number

Z-1929-2020

Quantity

86 units

Firm Location

Austin, TX

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.

Distribution

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

Lot / Code Info

All lots

Root Cause

Device Design

Action Taken

The firm requested its agents to identify and return affected devices.