FDA Enforcement
Class II
Ongoing
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Recall: Z-0761-2025
·
Reported January 1, 2025
Enforcement
- Recall Number
- Z-0761-2025
- Event ID
- 95882
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Encore Medical, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 1, 2025
- Initiation Date
- December 10, 2024
- Classification Date
- December 23, 2024
- Address
- 9800 Metric Blvd, Austin, TX, 78758-5445, United States
Description
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Reason
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Code Info
UDI-DI: 00888912167338. Lot: 076T1273A
Distribution
US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
Quantity
9