CLASS II Device recall · Reported 7 Nov 2012 · FDA Enforcement Report
Aviator Drill Bit recalled by Stryker Spine
Stryker Spine is recalling Aviator Drill Bit, distributed nationwide in the US. The recall was initiated on 5 Jul 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0163-2013
- FDA event ID
- 63272
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jul 2012
- FDA classified
- 29 Oct 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 5 Jul 2012 | Recall initiated by company | |
| 29 Oct 2012 | Classified by FDA | +116 days |
| 7 Nov 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
E207315 Catalog number 48770610, 48770612, 48770616 All lots
Where was it sold?
Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker Spine
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | AVS Anchor-C Cervical Cage System Instructions For Use recalled | Stryker Spine | Other | Nationwide |
Other Spinal Implants recalls
All 1,159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |