EMPOWR Hip Implant Components Recalled Due to Packaging Discrepancy
Encore Medical is recalling EMPOWR Dual Mobility hip acetabular components due to incorrect tibial inserts being packaged with products. The discrepancy was discovered through a customer complaint.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves packaging errors that could result in patients receiving incompatible implant components. While no injuries have been reported and the discrepancy was discovered via customer complaint, the risk-of-harm potential from device incompatibility or implant failure meets criteria for High severity per the rubric's criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Encore Medical, LP is recalling EMPOWR Acetabular Dual Mobility components (Model 952-28-42F and 952-28-40E) due to incorrect tibial inserts/implants being packaged with the products. The packaging discrepancy was discovered via a customer complaint.
Approximately 36 devices were distributed across the United States to medical device suppliers in Virginia, Texas, Florida, Tennessee, North Carolina, New York, Maryland, California, Louisiana, Indiana, Michigan, Alabama, and Utah. Of these, 35 remain in the field and 1 is in manufacturer inventory, with 1 device having been returned.
Patients who received these components could experience device incompatibility or implant failure if the incorrect components were used in surgery. The EMPOWR system requires specific component matching for proper function.
Patients and healthcare providers should verify that correct components were implanted and contact their medical supplier or Encore Medical if there are concerns about which components were received or used.
The recalled product
- Product
- 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 femora
- Manufacturer
- Encore Medical, LP
- Hazard
- packaging-error
- device-incompatibility
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Item: 952-28-42F GTIN: 00190446673200 Lot: 2225A1124
Distribution
Distributed in 14 states:
- AL
- CA
- FL
- IN
- LA
- MD
- MI
- NC
- NY
- TN
- TX
- UT
- VA
- VT
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03