The FDA announced on Dec. 28, 2017, that IMPLANTCAST GMBH is recalling the 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component due to a Class II hazard. The agency reported the recall was voluntary and firm-initiated.
How to tell if you have it
- Brand: IMPLANTCAST
- Product: 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component
- 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
- Distribution: Europe and U.S. states of Texas, Rhode Island and Georgia
The hazard
The hazard involves the possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Context
GovInfoNow's records show IMPLANTCAST GMBH has 1 other recall on record since 2021-05-10. On 2021-05-10, the company recalled EcoFit cup cementless due to a risk of loose plugs during bone impact. Other recent recalls of similar products include U2 Total Knee System Femoral Offset Bushing Recall (2026-03-19), ConMed Suture Anchor Recall (2026-07-14), and Zimmer Persona Revision Femoral Distal Augment Recall (2026-05-11).