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FDA (Device enforcement)Recalled 2026-01-05class ii

Encore Medical, LP: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Hazard

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Details from the source

Reason for recall: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. Distribution: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA Quantity: 19 Lot/code info: UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026

UPC codes

00888912167529

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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