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Z-1459-2026Class II

Encore Medical, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Encore Medical, LP
Product type
Device
Status
Ongoing
Report date
2026-03-04
Distribution
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Firm state
TX
Product quantity
14 implants
Initiated by
Voluntary: Firm initiated
Reason for recall

Knee and Humeral socket implants contain incorrect labeling.

Product description

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

Code / lot info

Lot Code: Lot: 151T1055A GTIN: 00888912167147

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →