FDA-Device2018-08-01Class II
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652
IMPLANTCAST GMBH
Hazard
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Sold states
Distribution in Europe and US states of Texas, Rhode Island and Georgia.
Affected count
304, 3 in US
Manufactured in
Luneburger Schanze 26, N/A, Buxtehude, N/A, Germany
Products
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2517-2018Don't want to check this manually?
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