medical Class II Updated 2020-10-28

Encore Medical, LP recalls EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster

Recalled Product

EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.


Hazard / Issue

Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 940-02-54G Lot Number: 801Z1036
View official government recall

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