Z-1479-2008

Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized...

Name: Z-1479-2008 Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized...
Creator: Abbott Spine
Published: 2008-02-13
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2008-02-13 / Terminated / root cause: design

FDA source

Abbott Spine began a recall of Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System... on 2008-02-13. The reason FDA records is "Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to...". 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-1479-2008
Status: Terminated
Initiated: 2008-02-13
Posted: 2008-07-23
Terminated: 2008-07-28
Recalling firm: Spinal Concepts, Inc.
Product: Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm notified sales reps regarding the recall by phone on 02/13/08. The sales reps were instructed to discontinue kit use in surgeries and to return inventory. Surgeons who had used the Sequoia System in surgery were notified of the recall via letter on 02/20/08. Surgeons were asked to monitor for post-operative dissociation in implanted patients and to notify Abbott Spine sales reps if any incidences occur.
Quantity in commerce: 38 surgical kits.
Distribution: Nationwide Distribution including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MN, NC, OH, OK, OR, PA, TX, VA and WI.
Product codes and lots: Part Numbers: 3300-0001-PL and 3300-0002-PL.

Product code NKB

K072672Class IISequoia Spinal System, Model 3300 SeriesAbbott Spine, Inc. / cleared 2007-11-28

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)