Z-0354-2007

TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system

Name: Z-0354-2007 TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system
Creator: Abbott Spine
Published: 2006-11-07
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2006-11-07 / Terminated

FDA source

Abbott Spine began a recall of TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system on 2006-11-07. The reason FDA records is "Tip of devices may dislodge while in use during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0354-2007
Status: Terminated
Initiated: 2006-11-07
Posted: 2007-01-17
Terminated: 2007-10-11
Recalling firm: Spinal Concepts, Inc.
Product: TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: Tip of devices may dislodge while in use during surgery.
FDA root cause: Other
Action: All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments.
Quantity in commerce: 76 units.
Distribution: Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus
Product codes and lots: Part #2665-1-07 (7mm), 2665-1-09 (9mm), 2665-1-11 (11mm), 2665-1-13 (13mm), 2665-1-15 (15mm).

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)