Z-1459-2026 Class II Ongoing
FDA device recall Z-1459-2026 was initiated by Encore Medical, LP on January 15, 2026 and is designated Class II. Reason for recall: Knee and Humeral socket implants contain incorrect labeling. The recall status is ongoing. Affected quantity: 14 implants.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2026
- Initiation Date
- January 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 implants
Product Description
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Reason for Recall
Knee and Humeral socket implants contain incorrect labeling.
Distribution Pattern
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Code Information
Lot Code: Lot: 151T1055A GTIN: 00888912167147