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.
Beginning in february 2011, stryker spine began receiving reports related to the shaft of the avs navigator trial failing at the junction of the trial head.
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Stryker sent an "URGENT PRODUCT RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was included for customers to complete and return via fax to Regulatory Compliance at 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this recall.
Stryker AVS Navigator Trials 6mm-15mm || Manufactured by: || Stryker Spine SAS || Z.1 Marticot-33610-Cestas -France || +33 (0) 5.57.97.06.30 || http;//www.stryker.com || Distributed in the USA by || Stryker Spine || 2 Pearl Court. Allendale || NJ 07401-1677 USA || +1-201-780-8000 || Cestas France 33610. || Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.