U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Labeling issue: the large xia anterior staple was laser marked with an "s", indicating small.
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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.
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.