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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Detail

Product Description Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
Recall Number Z-0163-2013
Classification Class II
Code Info E207315 Catalog number 48770610, 48770612, 48770616 All lots
Product Distributed Qty 6154 units
Reason For Recall Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.

Event Detail

Event Id 63272
Product Type Devices
Status Ongoing
Recalling Firm Stryker Spine
City Allendale
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution.