Encore Medical Recalls EMPOWR Dual Mobility Hip Implants for Packaging Error
Encore Medical is recalling EMPOWR Dual Mobility hip implants due to incorrect components being packaged. Approximately 35 devices are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with a packaging/component discrepancy but no reported illnesses, injuries, or hospitalizations. The small number of affected units and proactive recall before patient harm occurred justify the Moderate classification.
Plain-English summary
Encore Medical, LP is recalling the EMPOWR Dual Mobility acetabular hip implant system (Model 952-28-40E and 952-28-42F) due to a packaging discrepancy where incorrect tibial inserts or implant components were packaged with the devices. The issue was identified through a customer complaint.
Approximately 35 EMPOWR Dual Mobility hip implants were distributed to surgical centers and medical device distributors across the United States. One unit was returned from the field. One additional unit remains in the manufacturer's warehouse.
Patients who received this implant should contact their surgeon or healthcare provider if they have concerns about whether the correct components were implanted. Healthcare providers should verify the correct components and contact Encore Medical with questions.
The recalled product
- Product
- 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 femora
- Manufacturer
- Encore Medical, LP
- Category
- Medical Device — Hip Implant
- Hazard
- packaging-error
- wrong-component
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: 952-28-40E GTIN: 00190446673194 Lot\s: 2224A1124A
Distribution
Distributed in 14 states:
- AL
- CA
- FL
- IN
- LA
- MD
- MI
- NC
- NY
- TN
- TX
- UT
- VA
- VT
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