FDA Device recall 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…
- FDA Device
- Class II
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class II recall of 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… by Stryker Spine, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0163-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-05 |
| Published | 2012-11-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Spine |
| Distribution | US |
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.
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.
Identifiers
| code_info | E207315 Catalog number 48770610, 48770612, 48770616 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0163-2013%22
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