Recall Z-0508-2009 ยท MQP Spinal Vertebral Body Replacement Device
Alphatec Spine, Inc.
Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
| Date | Dec 31, 2008 (initiated Aug 16, 2007) |
| Status | Terminated |
| Reason | Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881. |
| Root cause | Process control |
| Action | The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back. |
| Quantity | 4 units |
| Distribution | Nationwide Distribution --- including states of AZ, FL, NY & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050553 | NOVEL VBR SPINAL SYSTEM Alphatec/Nexmed, Apr 18, 2005 |