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Recall Observatory FDA recall evidence

Device product

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

Z-1459-2026

January 15, 2026

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 98340
Status
Ongoing
Classification
Class II
Quantity
14 implants
Official record key
device-enforcement:Z-1459-2026

Official wording

Reason: Knee and Humeral socket implants contain incorrect labeling.

Code information: Lot Code: Lot: 151T1055A GTIN: 00888912167147

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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect labeling