Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EMPOWR Acetabular System Recalled by Encore Medical, LP Due to The firm received complaints that the EMPOWR Acetabular...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Encore Medical, LP directly.
Affected Products
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.
Quantity: 86 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Encore Medical, LP
Encore Medical, LP has 54 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report