medical Class II Updated 2023-10-18

Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Recalled Product

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
View official government recall

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