Device product
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.
Z-0163-2013
Product summary
- Firm
- Stryker Spine
- Event
- Event 63272
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6154 units
- Official record key
device-enforcement:Z-0163-2013
Official wording
Reason: 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.
Code information: E207315 Catalog number 48770610, 48770612, 48770616 All lots
Distribution pattern: Nationwide distribution.
Derived failure modes
-
Unknown
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.