Device evidence

device-recall:cfres:169803

LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model¿ SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.

Official recall number

Z-0733-2019

Evidence summary

Product code: LZO
Recall status: Terminated
Event initiated: December 07, 2018
Root cause: Under Investigation by firm
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0733-2019