FDA-Device2022-11-02Class II
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Encore Medical, LP
Hazard
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
Sold states
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Affected count
4
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2023Don't want to check this manually?
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