Devices

Device Recall CORE Universal Driver

Model / Serial
Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593
Product Classification
Ear, Nose, and Throat Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
Product Description
CORE Universal Driver REF 5400- 99 Rx Only || This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
1 Event
- Recall of Device Recall CORE Universal Driver

Manufacturer

Stryker Instruments Div. of Stryker Corporation

Manufacturer Address
Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)