Stryker Spine 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Spine
Lot Codes / Batch Numbers
lot code HJ3
Products Sold
lot code HJ3
Stryker Spine is recalling Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spi due to Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026