Z-0125-2023Class II

EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component

Name: Z-0125-2023 EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component
Creator: Encore Medical, LP
Published: 2022-08-12
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2022-08-12 / Open, Classified / root cause: manufacturing process

FDA source

Encore Medical, LP began a recall of EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component on 2022-08-12. FDA classified it as Class II and gives the reason as "Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0125-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-12
Posted: 2022-10-21
Recalling firm: Encore Medical, LP
Product: EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 8/12/22, recall notices were emailed to DJO Surgical Agents who were informed to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected devices have been transferred. 2) Return affected devices 3) Complete and return the response form Questions, contact: [email protected]
Quantity in commerce: 4
Distribution: US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Product codes and lots: UDI-DI/Lot: 00190446309833/629Z1085

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0125-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-21
Z-0126-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-21

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)