Recall Z-1929-2020— Encore Medical, LP

Name: FDA recall Z-1929-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-22

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2019-10-22. It names one FDA 510(k) clearance: K190057. Product: 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.. Reason: 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..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2019-10-22
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K190057 — DJO Acetabular SystemEncore Medical L.P.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.