Z-0294-06

SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems

Name: Z-0294-06 SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems
Creator: Abbott Spine
Published: 2005-11-14
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2005-11-14 / Terminated / root cause: labeling and UDI

FDA source

Abbott Spine began a recall of SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems on 2005-11-14. The reason FDA records is "Modification to labeling for surgical implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0294-06
Status: Terminated
Initiated: 2005-11-14
Posted: 2005-12-17
Terminated: 2007-10-02
Recalling firm: Spinal Concepts, Inc.
Product: SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Modification to labeling for surgical implant.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.
Quantity in commerce: Approximately 984 SC-AcuFix Corpectomy Surgical Techniques
Distribution: Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
Product codes and lots: SC-AcuFix Corpectomy Surgical Techniques: Doc #499-0057-MKC, rev A.

Product code KWQ

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)