FDA-Device2023-10-04Class II

MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

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

Product is labeled with incorrect offset.

Sold states
Domestic distribution to AL, NJ, NV.
Affected count
8 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2641-2023

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