Class 2 Device Recall THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM

• Date Initiated by Firm: January 18, 2011
• Date Posted: May 19, 2011
• Recall Status: Terminated on October 27, 2011
• Recall Number: Z-2202-2011
• Recall Event ID: 58179
• 510(K)Number: K032064
• Product Classification: Spinal vertebral body replacement device - Product Code MQP
• 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).
• Code Information: 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.
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: 609-275-0500
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 93 Kits
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQP and Original Applicant = THEKEN SURGICAL,LLC