IMPLANTCAST GMBH recalls 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF numbe…

Recall date

December 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2517-2018

FDA classification

Class II

Brand / firm

IMPLANTCAST GMBH

Sold / distributed

Distribution in Europe and US states of Texas, Rhode Island and Georgia.

Why it was recalled

Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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