Recall Z-2517-2018 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
IMPLANTCAST GMBH
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
| Date | Dec 28, 2017 |
| Status | Terminated |
| Reason | Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted. |
| Root cause | Process design |
| Action | Implantcast sent customers an Urgent Product Safety Information / Product Recall letter on December 28, 2017. The letter recommends that physicians follow their patients by radiological exam. There is a return form for the hospital or physician to confirm receipt of the letter. |
| Quantity | 304, 3 in US |
| Distribution | Distribution in Europe and US states of Texas, Rhode Island and Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.