International Medical Devices Database

Manufacturer Address
Ascension Orthopedics, Inc, 8700 Cameron Rd Ste 100, Austin TX 78754-3947
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA
1 Event
- Recall of Device Recall First Choice Partial Ulnar Head System ("DRUJ System").

One device in the database

Device Recall First Choice Partial Ulnar Head System ("DRUJ System").

Model / Serial
This recall applies to all of the First Choice DRUJ Partial Ulnar Head Devices. All lot numbers of the following Catalog Numbers are included: DRUJ-610-1445-WW, DRUJ-610-1455-WW, DRUJ-610-1465-WW, DRUJ-610-1645-WW, DRUJ-610-1655-WW, DRUJ-610-1665-WW, DRUJ-610-1745-WW, DRUJ-610-1755-WW, DRUJ-610-1765-WW, DRUJ-610-1945-WW, DRUJ-610-1955-WW, and DRUJ-610-1965-WW.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution.
Product Description
Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. || The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis

3 manufacturers with a similar name

Learn more about the data here

Ascension Orthopedics, Inc

Manufacturer Address
Ascension Orthopedics, Inc, 8200 Cameron Rd Ste C-140, Austin TX 78754-3832
Source
USFDA

Ascension Orthopedics, Inc

Manufacturer Address
Ascension Orthopedics, Inc, 8700 Cameron Rd Ste 100, Austin TX 78754
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA

Ascension Orthopedics, Inc

Manufacturer Address
Ascension Orthopedics, Inc, 8200 Cameron Road, Ste C-140, Austin TX 78754-3832
Source
USFDA

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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.

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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.

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