Device Recall Stryker Spine

  • Model / Serial
    E207315 Catalog number 48770610, 48770612, 48770616 All lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot #144933, 14D252, and 14D253.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France || Used to facilitate insertion of the Aero-AL cage into the disc space.
  • Manufacturer
  • Model / Serial
    K093670   Catalog numbers:  Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048  All lots of the above
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long || 5) Mini. || Allows for positioning directly on the midline keel of the occiput.
  • Manufacturer