FDA recall, , Moderate risk
Encore Medical Reverse Shoulder Prosthesis and EMPOWR 3D Knee Inserts
Knee and humeral socket implants contain incorrect labeling.
Summary by Recall Canary from the FDA notice
What happened
Encore Medical, LP of Austin, Texas, recalled RSP Humeral Socket Insert, RSP Standard Humeral Socket Insert, and Empowr 3D Knee Ins implants because the knee and humeral socket implants contain incorrect labeling. The recall began January 15, 2026, and was added to the FDA's Enforcement Report on February 24, 2026.
Distribution was nationwide in states including Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida, and California.
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?
3 products
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Reverse Shoulder Prosthesis (RSP) RSP Humeral Socket Insert, 32MM +4MM, Standard HXe-plus
- UDI-DI
- 00888912144575
- Model/Catalog number
- 509-00-432
- Lot code
- 385P1263
Reverse Shoulder Prosthesis (RSP) RSP Standard Humeral Socket Insert, 36MM, HXe-plus
- UDI-DI
- 00888912144544
- Model/Catalog number
- 509-00-036
- Lot code
- 378P1382
Empowr 3D Knee INS, 7L 16MM, VE
- UDI-DI
- 00888912167147
- Model/Catalog number
- 341-16-707
- Lot code
- 151T1055A
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida, California.
- Company
- Encore Medical, LPAustin, Texas
- Hazard
- Labeling error
- 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
- 98340
- Recall numbers
- Z-1458-2026 to Z-1460-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
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
