CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report

Empowr Dual Mobility" Empowr Acetabular, Dual Mobility recalled

Encore Medical is recalling Empowr Dual Mobility" Empowr Acetabular, Dual Mobility, Poly Bearing, ID28, OD42, distributed in 17 states. The recall was initiated on 12 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Item: 952-28-42F GTIN: 00190446673200 Lot: 2225A1124

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2148-2025
FDA event ID: 97094
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 12 Jun 2025
FDA classified: 21 Jul 2025
Reported: 30 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

12 Jun 2025	Recall initiated by company
21 Jul 2025	Classified by FDA	+39 days
30 Jul 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stems Component: NA

Where it was distributed

RFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Valor Medical Solutions South Texas (TX) CE118 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 4 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 2 WHISKEY TRAIL ORTHOPEDICS LLC AUS Tennessee (TN) CE123 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1 Florida Direct - FSW Medical Florida (FL) FL001 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Certus Medical LLC Indiana (IN) & Michigan (MI) GL112 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1 Procore Medical, LLC North Carolina (NC) MA102 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 2 Implant Medical Sales, Inc. New York (NY) NE190 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1 Maryland Medical Devices LLC Maryland (MD) NE192 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 3 CalSurg California (CA) NW115 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1 Del Ortho LLC Louisiana (LA) SC195 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 2 Joint Medical Solutions, LLC Alabama (AL) SE180 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1 VT Industries, LLC Florida (FL) SE194 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1 Promedica Utah (UT) W176 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Diverse Surgical Supplies California (CA) W193 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Unified Orthopedics Southern California W223 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 5 Totaling 36 devices and of those the following have been returned CE118 returned 1 device due to complaint CC-00488572: 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 This leaves a total of 35 in the field. Encore Medical L.P. (Enovis) has the following 1 device in the warehouse: 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Complaint CC-00488572

Alabama California Florida Indiana Louisiana Massachusetts Maryland Michigan North Carolina Nebraska New York South Carolina Tennessee Texas Utah Virginia Vermont

Questions about this recall

Why was it recalled?

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

Which lots are affected?

Lot Code: Item: 952-28-42F GTIN: 00190446673200 Lot: 2225A1124

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97094

This product is part of a recall event; the main page for the event is Empowr Dual Mobility" Empowr Acetabular, Dual Mobility recalled.

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025	CLASS II	Empowr Dual Mobility" Empowr Acetabular, Dual Mobility recalled	Encore Medical	Packaging Defects	17 states

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