Recall Z-2202-2011 ยท MQP Spinal Vertebral Body Replacement Device
Integra LifeSciences Corp.
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
| Date | May 19, 2011 (initiated Jan 18, 2011) |
| Status | Terminated |
| Reason | 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 | 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 en |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032064 | THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM Theken Surgical,Llc, Feb 20, 2004 |