Devices

Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

Model / Serial
REF 89-7639.01 - Lot Number 24579045 REF 89-7639.01 - Lot Number 24664258 REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
(USA) including Indiana
Product Description
Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits
Manufacturer
DeRoyal Processing Center
1 Event
- Recall of Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

Manufacturer

DeRoyal Processing Center

Manufacturer Address
DeRoyal Processing Center, 1703 Highway 33 S, New Tazewell TN 37825-5043
Manufacturer Parent Company (2017)
Deroyal Industries Inc.
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)