PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 1, 2025 Initiated: December 10, 2024 #Z-0761-2025

Product Description

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.

Details

Recalling Firm
Encore Medical, LP
Units Affected
9
Distribution
US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
Location
Austin, TX

Frequently Asked Questions

What product was recalled?
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706. Recalled by Encore Medical, LP. Units affected: 9.
Why was this product recalled?
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0761-2025.