FDA-Device2020-10-28Class II
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.
Encore Medical, LP
Hazard
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.
Sold states
U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
Affected count
12 cups
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0135-2021Don't want to check this manually?
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