EMPOWR 3D Knee Tibial Insert recall
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Why was EMPOWR 3D Knee Tibial Insert recalled?
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
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: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
- Product
- EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
- Recalling firm
- Encore Medical, LP
- Quantity
- 36
- Distribution
- US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
- Recall date
- October 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)