Stryker Spine: Medical Device Recall in 2012 - (Recall #: Z-0163-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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) 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.

Product Classification:

Class II

Date Initiated: July 5, 2012

Date Posted: November 7, 2012

Recall Number: Z-0163-2013

Event ID: 63272

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.

Status: Terminated

Product Quantity: 6154 units

Code Information:

E207315 Catalog number 48770610, 48770612, 48770616 All lots

Distribution Pattern:

Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated