Recall Z-0508-2009
Alphatec Spine, Inc. · initiated August 16, 2007
Product
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.
Codes / lots: Lot Number: 611881
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.
FDA-determined 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.
Details
- Recall number
- Z-0508-2009
- Initiated
- August 16, 2007
- Posted by FDA
- December 31, 2008
- Terminated
- January 12, 2009
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Quantity
- 4 units
- Distribution
- Nationwide Distribution --- including states of AZ, FL, NY & TX.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0507-2009 | Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the…Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong… | 08/16/2007Terminated |