Encore Medical Recalls EMPOWR 3D KNEE Implants Due to Incorrect Labeling
Encore Medical, LP has issued a voluntary recall for EMPOWR 3D KNEE implants distributed across 17 states due to labeling errors on the packaging.
What Happened
Encore Medical, LP has initiated a voluntary recall of specific EMPOWR 3D KNEE implants. The recall was triggered because the knee and humeral socket implants were found to contain incorrect labeling. This labeling error could lead to confusion regarding the product’s specifications during surgical procedures.
Which Products Are Affected
The recall affects 14 implants with the following specifications:
- Brand Name: EMPOWR 3D KNEE
- Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE
- Model/Catalog Number: 341-16-707
- Lot Code: 151T1055A
- GTIN: 00888912167147
- Recall Number: Z-1459-2026
Distribution was limited to the following U.S. states: VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
What You Should Do
Healthcare providers and facilities should immediately check their inventory for the affected lot code (151T1055A). The firm initiated the recall notification via letter on January 15, 2026. If you have these products in your possession, follow the instructions provided in the notification letter regarding the return or replacement of the units. For further inquiries, contact Encore Medical, LP at their Austin, Texas location.
Why This Matters
Correct labeling is essential for medical devices to ensure that surgeons select the appropriate components for patients. Incorrect labeling on implants can lead to surgical complications or the use of improper medical hardware.
Source
This information is sourced from the FDA (Recall Event ID: 98340).
Source: FDA Official Notice