EMPOWR 3D Knee Tibial Insert recall
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Why was EMPOWR 3D Knee Tibial Insert recalled?
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00888912167338. Lot: 076T1273A
- Product
- EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
- Recalling firm
- Encore Medical, LP
- Quantity
- 9
- Distribution
- US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
- Recall date
- January 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)