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Lower risk Medical device recall · FDA · Published June 12, 2025

EMPOWR Dual Mobility Hip Implant Recall: Incorrect Tibial Inserts Packaged

Encore Medical recalls EMPOWR Dual Mobility hip implants (model 952-28-40E) due to incorrect tibial inserts being packaged. Affected patients should contact the manufacturer for details.

🇺🇸 FDA recall #Z-2147-2025Medical deviceEMPOWR ›
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Contact the company

Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445
✎ GovInfoNow plain-language explainer

Encore Medical is recalling EMPOWR Dual Mobility hip implants because they were packaged with the wrong tibial inserts. This could lead to improper joint fitting and potential complications after surgery. Read more at govinfonow.com/recall/52051-empowr-dual-mobility-hip-implant-recall-incorrect-tibial-inserts-packaged.

Source Summary by GovInfoNow · govinfonow.com/recall/52051-empowr-dual-mobility-hip-implant-recall-incorrect-tibial-inserts-packaged · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2147-2025

Cite this page

“EMPOWR Dual Mobility Hip Implant Recall: Incorrect Tibial Inserts Packaged.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52051-empowr-dual-mobility-hip-implant-recall-incorrect-tibial-inserts-packaged. Based on FDA recall #Z-2147-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2025%22&limit=1).

The FDA announced on June 12, 2025, that Encore Medical, LP is recalling the EMPOWR Dual Mobility system due to a packaging discrepancy where incorrect tibial inserts were packaged. The agency issued recall number Z-2147-2025 for the Class II voluntary recall.

How to tell if you have it

  • Brand: EMPOWR
  • Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40
  • Model/Catalog Number: 952-28-40E
  • Lot Code: 2224A1124A
  • GTIN: 00190446673194

The hazard

The recall is due to a packaging discrepancy with incorrect tibial inserts or implants being packaged, which was discovered via a customer complaint. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Encore Medical, LP has issued 43 other recalls since May 31, 2017. Recent Encore recalls include the Feb. 16, 2026 EMPOWR 3D KNEE Ins 11L 14MM VE packaging mix-up and the Jan. 15, 2026 RSP Humeral Socket Insert labeling error. Other recent recalls of similar products include the Howmedica TRIATHLON Hinge Insert recall (July 30, 2026) and the Howmedica OMNIFIT Series I Acetabular Insert recall (July 30, 2026).

How to tell if you have this one

Check for the model number 952-28-40E on the implant packaging. The lot code 2224A1124A is also associated with this recall.

  • Brand
    EMPOWR
  • Product
    Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    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 numberProduct, codes & lots
Z-2147-2025Brand 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; Lot Code: Item: 952-28-40E GTIN: 00190446673194 Lot\s: 2224A1124A
Z-2148-2025Brand 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; Lot Code: Item: 952-28-42F GTIN: 00190446673200 Lot: 2225A1124
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Encore Medical for specific instructions about your implant.

Where it went and when

Where it was distributed

Distributed in 14 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Florida, Idaho, Indiana, Louisiana, Maryland, Michigan, New York, North Carolina, Tennessee, Texas, Utah, Virginia.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Jun 12, 202512. FDA classified it Class II: Jul 21, 202523. Published in FDA’s Enforcement Report: Jul 30, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2147-2025 (June 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2147-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA