Devices

Device Recall Stryker Spine

Model / Serial
E207315 Catalog number 48770610, 48770612, 48770616 All lots
Product Classification
Orthopedic Devices
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
Stryker Spine
1 Event
- Recall of Device Recall Stryker Spine

Manufacturer

Stryker Spine

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

2 devices with a similar name

Learn more about the data here

Device Recall Stryker Spine

Model / Serial
Lot #144933, 14D252, and 14D253.
Product Classification
Orthopedic Devices
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
Stryker Spine

Device Recall Stryker Spine Oasys Midline Occiput Plate

Model / Serial
K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
Product Classification
Orthopedic Devices
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
Stryker Spine

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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