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.
The xia 3 8.5mm polyaxial screws, lot a91109 were anodized turquoise instead of fuchsia. the turquoise color is reserved for the 9.5 mm xia 3 screws.
조치
Stryker Spine branches that received the recalled product were notified of the recall by an Urgent Product Recall letter, dated January 15, 2010, sent via Federal Express. The letter identified the affected product and the issue involved. It also discussed the potential hazards, risk mitigation, and the return process. Customers are to examine their inventory and hospital locations to identify the product. Customers are also to reconcile the product by utilizing the Customer Response Form and distribution sheet. In addition, they are to retrieve and return the affected product. Questions should be directed to Tiffani Rogers at 201-760-8206.
Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. || Not Sterile; || Manufactured by Stryker Spine, SA, Cestas, France. || Distributed in the USA by Stryker Spine, Allendale, NJ || Intended for use in the noncervical spine.