Z-0554-2010

Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for...

Name: Z-0554-2010 Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for...
Creator: Zimmer Inc.
Published: 2009-08-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-08-20 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system on 2009-08-20. The reason FDA records is "The tip of the instrument may fracture during use". 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-0554-2010
Status: Terminated
Initiated: 2009-08-20
Posted: 2009-12-22
Terminated: 2011-04-13
Recalling firm: Zimmer GmbH
Product: Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: The tip of the instrument may fracture during use.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).
Quantity in commerce: 215
Distribution: Nationwide, Belgium and New Zealand.
Product codes and lots: Lots 47PN, 47PP, 49HK, 49HL and 57WL.

Product code NKB

K082032Class IISequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310)Abbott Spine, Inc. / cleared 2008-10-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)