Device 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.
Z-0135-2021
Product summary
- Event
- Event 86450
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 cups
- Official record key
device-enforcement:Z-0135-2021
Official wording
Reason: 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.
Code information: Model Number: 940-02-54G Lot Number: 801Z1036
Distribution pattern: U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
Derived failure modes
-
Unknown
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.