Z-0507-2009

Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine...

Name: Z-0507-2009 Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine...
Creator: Alphatec Spine, Inc.
Published: 2007-08-16
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2007-08-16 / Terminated / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of 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... on 2007-08-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0507-2009
Status: Terminated
Initiated: 2007-08-16
Posted: 2008-12-31
Terminated: 2009-01-12
Recalling firm: Alphatec Spine, Inc.
Product: 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.
Product code: MQP Spinal Vertebral Body Replacement Device
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 3 units
Distribution: Nationwide Distribution --- including states of AZ, FL, NY & TX.
Product codes and lots: Lot Number: 611884

Product code MQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)