Reported Nov 7, 2012 · Terminated

Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France…

Stryker Spine

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611

Is this the product you have?

    • Aviator Drill Bit (10 mm
    • 12 mm
    • 14 mm
    • 16 mm
  • Manufactured byStryker 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
Lot codes and dates
    • E207315 Catalog number 48770610
    • 48770612
    • 48770616 All lots
Amount recalled
6154 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 28, 2013 · Data as of Sep 19, 5:26 PM UTC

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