Home › Ascension Orthopedics, Inc. › Ascension® First Choice® DRUJ System
Ascension® First Choice® DRUJ System
Ascension Orthopedics, Inc. · Model DRUJ6101455WW · UDI-DI 10381780123552
KXE
Prescription
1
510(k) clearances
44
Adverse events
3
Recalls
18
Facilities
Description
The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ulnar head replacement. It has a distal articular head and proximal intramedullary stem. The cobalt chromium implant head articulates with the radius and the carpal bones of the wrist. These features match native ulnar head articulation. The implant is inserted into the medullary canal of the ulna following resection of the ulnar head. It is designed to be a press fit device that achieves fixation by means of direct implant/bone appositions.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-06-24 | Stryker Howmedica Osteonics Corp. | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromise |
| 2015-06-24 | Stryker Howmedica Osteonics Corp. | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromise |
| 2011-12-03 | Ascension Orthopedics, Inc | A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filin |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.