Z-0603-2011

Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01

Name: Z-0603-2011 Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01
Creator: Zimmer Inc.
Published: 2005-12-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2005-12-01 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01 on 2005-12-01. The reason FDA records is "The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site". 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-0603-2011
Status: Terminated
Initiated: 2005-12-01
Posted: 2010-12-10
Terminated: 2011-06-01
Recalling firm: Zimmer GmbH
Product: Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Root cause tag: design
FDA root cause: Device Design
Action: The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
Quantity in commerce: 220
Distribution: Worldwide Distribution, including US.
Product codes and lots: Lots 16HU, 18FL, 19GC, 21BS and 29CK.

Product code KWQ

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)