Z-0103-2024Class II

EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H

Name: Z-0103-2024 EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H
Creator: Encore Medical, LP
Published: 2023-08-22
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-08-22 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H on 2023-08-22. FDA classified it as Class II and gives the reason as "Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0103-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-22
Posted: 2023-10-12
Recalling firm: Encore Medical, LP
Product: EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 8/22/23, recall notices were emailed to agents who were asked to do the following: 1) Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. 2) The notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. If you have any questions, email [email protected]
Quantity in commerce: 20
Distribution: US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
Product codes and lots: UDI-DI: 00190446309833, Lot: 629Z1114, Expiration: March 30, 2028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0103-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0102-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12
Z-0103-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)