PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 1, 2018 Initiated: December 28, 2017 #Z-2517-2018

Product Description

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.

Details

Recalling Firm
IMPLANTCAST GMBH
Units Affected
304, 3 in US
Distribution
Distribution in Europe and US states of Texas, Rhode Island and Georgia.
Location
Buxtehude, N/A

Frequently Asked Questions

What product 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. Recalled by IMPLANTCAST GMBH. Units affected: 304, 3 in US.
Why was this product recalled?
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2517-2018.