Z-0502-06

TraXis Vue Spinal Implant System, Part #2601-090921

Name: Z-0502-06 TraXis Vue Spinal Implant System, Part #2601-090921
Creator: Abbott Spine
Published: 2005-11-02
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2005-11-02 / Terminated / root cause: manufacturing process

FDA source

Abbott Spine began a recall of TraXis Vue Spinal Implant System, Part #2601-090921 on 2005-11-02. The reason FDA records is "Implants were manufactured without radiographic markers". 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-0502-06
Status: Terminated
Initiated: 2005-11-02
Posted: 2006-02-07
Terminated: 2007-09-25
Recalling firm: Spinal Concepts, Inc.
Product: TraXis Vue Spinal Implant System, Part #2601-090921
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: Implants were manufactured without radiographic markers.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot.
Quantity in commerce: 41 units
Distribution: Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
Product codes and lots: Lot #2010292

Product code MQP

K031855Class IISpinal Concepts, Inc. Insight Pedicle Screw SystemSpinal Concepts, Inc. / cleared 2003-09-17

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)