FDAFDA · Food and drugs·Recall number Z-0163-2013
Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, 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 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.
Published November 7, 2012 · Recall initiated: July 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Spine
- Distributor
- Nationwide distribution.
- Lot
- E207315 Catalog number 48770610, 48770612, 48770616 All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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