Z-1525-2009

Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS...

Name: Z-1525-2009 Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS...
Creator: Stryker Spine
Published: 2007-04-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-04-12 / Terminated / root cause: labeling and UDI

FDA source

Stryker Spine began a recall of Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France; Distributed by Howmedica Osteonics... on 2007-04-12. The reason FDA records is "Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1525-2009
Status: Terminated
Initiated: 2007-04-12
Posted: 2009-06-26
Terminated: 2009-06-29
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France; Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430 Single use device sterilized prior to use. For anterior/anterolateral and posterior noncervical pedicle and non-pedicle fixation for the following: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, psudoartrosis, and failed previous fusion.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Market Withdrawal letters were sent to Stryker branches who received product on April 13, 2007 by Federal Express. The letters asked that they examine their inventory and hospital locations to identify the implant; reconcile these implants on the attached Product Accountability Form and fax a copy to (201) 760-8456; retrieve and return the affected implants; and contact their Stryker Customer Service rep to re-order the product that they are returning as part of the regulatory action.
Quantity in commerce: 38 in US
Distribution: Nationwide Distribution.
Product codes and lots: lot code HJ3

Product code NKB

K060361Class IIXia Spinal System, Xia 4.5 Spinal SystemStryker Spine / cleared 2006-03-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)