Z-0880-05

SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An...

Name: Z-0880-05 SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An...
Creator: Spinal Concepts, Inc
Published: 2002-07-01
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2002-07-01 / Terminated

FDA source

Spinal Concepts, Inc began a recall of SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas on 2002-07-01. The reason FDA records is "Complaints were recieved where swivels came out of plate and where the screw went through the plate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0880-05
Status: Terminated
Initiated: 2002-07-01
Posted: 2005-06-11
Terminated: 2005-12-20
Recalling firm: Spinal Concepts, Inc.
Product: SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Complaints were recieved where swivels came out of plate and where the screw went through the plate.
FDA root cause: Other
Action: The firm initiated the recall via telephone communication from sales representatives around August 2002.
Quantity in commerce: 10 systems
Distribution: Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA
Product codes and lots: All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254

Product code KWQ

K013979Class IISc-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc. / cleared 2002-02-13

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)