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Class 2 Device Recall Stryker AVS Navigator |
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Date Initiated by Firm |
January 13, 2012 |
Date Posted |
July 19, 2012 |
Recall Status1 |
Terminated 3 on July 29, 2013 |
Recall Number |
Z-2033-2012 |
Recall Event ID |
61723 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product |
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. |
Code Information |
Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875. |
Recalling Firm/ Manufacturer |
Stryker Spine 2 Pearl Ct Allendale NJ 07401-1611
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For Additional Information Contact |
Ms. Michelle Barry 201-760-8287
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Manufacturer Reason for Recall |
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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FDA Determined Cause 2 |
Device Design |
Action |
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. |
Quantity in Commerce |
273 units |
Distribution |
Nationwide. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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