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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description 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.
Recall Number Z-2033-2012
Classification Class II
Code Info Class I; 510(k) Exempt Description: AVSĀ® 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.
Product Distributed Qty 273 units
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.

Event Detail

Event Id 61723
Product Type Devices
Status Ongoing
Recalling Firm Stryker Spine
City Allendale
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-01-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.
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