FDA recall Z-0761-2025

Encore Medical, LP · Class II · device

Product

EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Reason for recall

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

Distribution

US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.

Key facts

Status
Ongoing
Initiation date
2024-12-10
Report date
2025-01-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2025