Z-0502-2010

Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12

Name: Z-0502-2010 Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
Creator: Alphatec Spine, Inc.
Published: 2009-08-05
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2009-08-05 / Terminated / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 on 2009-08-05. The reason FDA records is "Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40...". 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-0502-2010
Status: Terminated
Initiated: 2009-08-05
Posted: 2009-12-14
Terminated: 2010-06-07
Recalling firm: Alphatec Spine, Inc.
Product: Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.
Quantity in commerce: 163 Units
Distribution: Nationwide distribution.
Product codes and lots: Lot Numbers: 624239, 624240

Product code KWP

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)