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Recall Observatory FDA recall evidence

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

September 09, 2020

Class II

Product summary

Firm
Encore Medical, LP
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

    reason.no_named_rule · v1.0.0

    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.