Recall Register

Food, drugs, devices › Encore Medical, LP

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

FDA enforcement event 90882 · Class II · initiated 12 Aug 2022 · status Ongoing

DeviceVoluntary: Firm initiated2 product recordsAustin, TX

Encore Medical, LP (Austin, TX) initiated this device recall on 12 Aug 2022; FDA lists 2 product records under event 90882, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Encore Medical, LP has 61 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Encore Medical, LP, Austin, TX.

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."

Distribution

"US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX."

Product records

Recall numberProductQuantityClassStatusReport date
Z-0125-2023EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.4Class IIOngoing2 Nov 2022
Z-0126-2023EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.18Class IIOngoing2 Nov 2022

Context

88%of 2022 device events are Class II839 events that year
2product records in this eventfirm median: 1
61events on this register for the firm

Other enforcement events for Encore Medical, LP

InitiatedProduct (first record)TypeClassRecords
16 Feb 2026Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product DescrDeviceClass II2
15 Jan 2026Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus ModeDeviceClass II3
5 Jan 2026EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705DeviceClass II2
18 Jul 2025Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 ProduDeviceClass II4
9 Jul 2025Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 34DeviceClass II2
12 Jun 2025Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/CatalogDeviceClass II2
2 Jun 2025Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number:DeviceClass II2
28 May 2025Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126DeviceClass II4
18 Dec 2024EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703DeviceClass II1
10 Dec 2024EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706DeviceClass II1

All 61 events for Encore Medical, LP

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.