Z-1929-2020Class II

EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029...

Name: Z-1929-2020 EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029...
Creator: Encore Medical, LP
Published: 2019-10-22
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2019-10-22 / Open, Classified / root cause: design

FDA source

Encore Medical, LP began a recall of 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... on 2019-10-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1929-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-22
Posted: 2020-05-08
Recalling firm: Encore Medical, LP
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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm requested its agents to identify and return affected devices.
Quantity in commerce: 86 units
Distribution: US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1929-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1929-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code LPH

K190057Class IIDJO Acetabular SystemEncore Medical L.P. / cleared 2019-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)