Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E 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
Why it was recalled
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Lot Code: Item: 952-28-40E GTIN: 00190446673194 Lot\s: 2224A1124A
Recall status
Ongoing — the recall is still being carried out.
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
Recall record
- Recalling firm
- Encore Medical, LP
- Product type
- Devices
- Recall number
- Z-2147-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Austin, TX
- Recall initiated
- 2025-06-12
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2147-2025 · Source: openFDA enforcement.