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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker AVS Navigator

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  Class 2 Device Recall Stryker AVS Navigator see related information
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
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
For Additional Information Contact Ms. Michelle Barry
201-760-8287
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.
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
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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