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.
FDA Recall Z-1929-2020 · Posted None
Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2019-10-22
Product Quantity86 units
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.
Firm Action
The firm requested its agents to identify and return affected devices.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.