FDA Device Intelligence
HomeDevice types › KXE

Prosthesis, Wrist, Hemi-, Ulnar

FDA product code KXE · Class 2 · Orthopedic

173
Registered devices
44
Adverse events
3
Recalls
16
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2015-06-24Stryker 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 poten
2015-06-24Stryker 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 poten
2011-12-03Ascension Orthopedics, IncA recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a s

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 docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.