—#98602

Product

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).

FDA product code: MQP — Spinal Vertebral Body Replacement Device
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032064
Affected lot / code info: 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.

Why it was recalled

Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool) that is not relevant to the devices' intended use.

Root cause (FDA determination)

Other

Action the firm took

The firm, Integra Spine, sent an "URGENT: RECALL NOTIFICATION" letter dated January 18, 2011, to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their current inventory and return all remaining kits; complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via fax to: 877-558-6227 or email: melissa.niosi@integralife.com, and contact Integra Spine Customer Service at 866-942-8698 regarding availability of suitable replacement products. Integra Spine will be taking immediate action to restore your inventory and ensure minimal impact on availability for surgical procedures. Should you have any additional questions, please feel free to contact me at 609-936-2495 or email at jon.caparotta@integralife.com.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-01-18
Posted by FDA: 2011-05-19
Terminated: 2011-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.