FDA recall Z-2517-2018

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-12-28

Report date

2018-08-01

Termination date

2020-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buxtehude, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2517-2018