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 mm12 mm14 mm16 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 487706104877061248770616 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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