FDA-Device2024-03-06Class II

LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12

Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard

Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

Sold states
Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
Manufactured in
Oststr. 4-10, Norderstedt, Germany
Products
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2024

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