Z-0808-04

1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are...

Name: Z-0808-04 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are...
Creator: Spinal Concepts, Inc
Published: 2004-03-01
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2004-03-01 / Terminated / root cause: design

FDA source

Spinal Concepts, Inc began a recall of 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott... on 2004-03-01. The reason FDA records is "Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0808-04
Status: Terminated
Initiated: 2004-03-01
Posted: 2004-07-20
Terminated: 2007-04-13
Recalling firm: Spinal Concepts, Inc.
Product: 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
Root cause tag: design
FDA root cause: Other
Action: The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
Quantity in commerce: 25 (1757-1)
Distribution: Nationwide
Product codes and lots: All lots

Product code KWQ

K024326Class IISpinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. / cleared 2003-01-23

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)