2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. ...
FDA Recall #Z-2517-2018 — Class II — December 28, 2017
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.
Recalling Firm
IMPLANTCAST GMBH — Buxtehude, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
304, 3 in US
Distribution
Distribution in Europe and US states of Texas, Rhode Island and Georgia.
Code Information
Article/Batch numbers: Size 38/39 mm REF number 02423839 Batch 150201G, 1504298, 1504299, 150429C, 150429L; Size 42/44 mm REF number 02424244 Batch 1702188, 15042AF, 15042A7, 15042A6, 15042A5; Size 44/48 mm REF number 02424448 Batch 1702189, 1637108, 16141C1; Size 46/52 mm REF number 02424652 Batch 1637109, 16141C2.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated