Home › Device 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
NA — APTIS MEDICAL, LLCNA — Stryker GmbHSeitz Solution Unlar Head — Kapp Surgical Instrument Co.UHEAD — Stryker GmbHNA — Stryker GmbHSeitz Solution Unlar Head — Kapp Surgical Instrument Co.UHEAD — Stryker GmbHUHEAD — Stryker GmbHAscension® First Choice® DRUJ System — Ascension Orthopedics, Inc.Ascension® First Choice® DRUJ System — Ascension Orthopedics, Inc.NA — APTIS MEDICAL, LLCNA — APTIS MEDICAL, LLCFirst Choice Partial Ulnar Head Implant — Smith & Nephew, Inc.UHEAD — Stryker GmbHAscension® First Choice® DRUJ System — Ascension Orthopedics, Inc.NA — Stryker GmbHUHEAD — Stryker GmbHNA — APTIS MEDICAL, LLCNA — APTIS MEDICAL, LLCNA — APTIS MEDICAL, LLCFirst Choice Modular Ulnar Head Implant — Smith & Nephew, Inc.NA — APTIS MEDICAL, LLCNA — APTIS MEDICAL, LLCNA — APTIS MEDICAL, LLC
Recent 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 poten |
| 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 poten |
| 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 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 docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.
