FDA recall, , Moderate risk
Encore Medical EMPOWR Knee and Hip Implants
Empowr Acetabular System and Empowr 3D Knee Tibial Insert may have a packaging discrepancy that could cause surgical delay or revision surgery.
Summary by Recall Canary from the FDA notice
What happened
Encore Medical, LP, based in Austin, Texas, voluntarily recalled the Empowr 3D Knee Tibial Insert 5R 14MM and the Empowr Acetabular System. The recall was initiated on January 5, 2026, and added to the FDA's Enforcement Report on February 2, 2026.
The reason for the recall is that one package of the 942-01-40G acetabular system was found to contain a 942-01-36H acetabular system; several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
The affected products include the Empowr 3D Knee Tibial Insert 5R 14MM and specific liners from the Empowr Acetabular System, such as the 10 degree Hooded, HXe+ liners in sizes 36H, 36J, 40G, and 32C.
The products were distributed across 13 states and territories, including Texas, Iowa, Michigan, Mississippi, Massachusetts, Rhode Island, New Jersey, Pennsylvania, New York, Missouri, Oklahoma, Puerto Rico, Alabama, and California. The packaging discrepancy may cause surgical delay to exchange devices or revision surgery.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE
- UDI-DI
- 00888912167529
- Reference number
- 342-14-705
- Lot code
- 139T1075A
Product details
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H;
Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J;
Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G;
Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C- UDI-DI
- 00190446309789
- 00190446309802
- 00190446309826
- 00190446309697
- Lot code
- 942-01-36H
- 624Z1032
- 942-01-36J
- 626Z1021
- 942-01-40G
- 628Z1034
- 942-01-32C
- 615Z1026
Recall details
- Company began the recall
- Sold in
- 13 states
- Company
- Encore Medical, LPAustin, Texas
- Hazard
- Packaging defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98177
- Recall numbers
- Z-1233-2026 to Z-1234-2026
- Recall type
- Voluntary: Firm initiated
All recalls from Encore Medical, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
