Device Recall THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM

Vu C POD VBR Kit Identification: 11-001 thru 11-123, 11-026 thru 11-032, 11-034 thru 11-042, 11-044, thru11-048, 11-051 thru 11-058, 11-060, 11-061, 11-062, 11-066 thru 11-072, 11-074 thru 11-087, & 11-102. Ti C POD VBR Kit Identification number: 04-017. Ti L POD VBR Kit Identification numbers: 05-004, 05-006, 05-008, 05-017, 05-023, 05-101, 05-103, 05-107, 05-108, 05-109, 05-112, 05-113, 05-115, 05-123 & 05-124.

Orthopedic Devices

2

Yes

Nationwide distribution: USA including states of: AL, AZ, CA, FL, ID, IL, MD, MI, NH, NM, NV, OH, OK, OR, PA, TX, UT and WI.

Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima¿ Vertebral Body Replacement System, c"POD" Titanium Vertebral Body Replacement System || The Theken CPOD / LPOD VBR is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken CPOD / LPOD VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.The Theken Vu C POD VBR System is indicated for use in the thoracolumbar spine (T1 -L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).