Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. 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.
This recall has been terminated (originally issued December 31, 2008).
- Company
- Alphatec Spine, Inc.
- Recall Initiated
- August 16, 2007
- Posted
- December 31, 2008
- Terminated
- January 12, 2009
- Recall Number
- Z-0507-2009
- Quantity
- 3 units
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution --- including states of AZ, FL, NY & TX.
Lot / Code Info
Lot Number: 611884
Root Cause
Process control
Action Taken
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.