Prosthesis, Wrist, Hemi-, Ulnar
Orthopedic · 21 CFR 888.3810
Recent MDR events
44 adverse event reports on file
- APTIS DRUJApr 2, 2026InjuryAptis Medical3004521401-2026-00002
- APTIS DRUJJan 2, 2026InjuryAptis Medical3004521401-2026-00001
- APTIS DRUJJul 6, 2023InjuryAptis Medical3004521401-2023-00001
- APTIS DRUJDec 16, 2021InjuryAptis Medical3004521401-2021-00001
- UNKNOWN REMOTION WRIST LEFT RADIAL IMPLANT SMALLJul 7, 2020InjuryStryker Gmbh0008031020-2020-01861
- UNKNOWN REMOTION WRIST CARPAL IMPLANT MEDIUMJul 6, 2020InjuryStryker Gmbh0008031020-2020-01847
- UNKNOWN REMOTION WRIST RIGHT RADIAL IMPLANT SMALLJul 6, 2020InjuryStryker Gmbh0008031020-2020-01855
- UNKNOWN CARPAL PLATEApr 20, 2020InjuryStryker Gmbh0008031020-2020-01372
- UNKNOWN RADIAL STEMApr 15, 2020InjuryStryker Gmbh0008031020-2020-01288
- UNKNOWN MOOVIS METACARPAL STEMAug 23, 2019InjuryStryker Gmbh0008031020-2019-01131
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Adverse Event Without Identified Device or Use Problem”
No history to chart.
Recalls
3 recall events for this product code
- Stryker Howmedica Osteonics Corp.TerminatedAug 20, 2015
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplas
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Z-2427-2015 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedAug 20, 2015
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection art
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Z-2430-2015 · View FDA record ↗ - Ascension Orthopedics, IncTerminatedFeb 17, 2012
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.
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 filing with the FDA.
Z-1060-2012 · View FDA record ↗
Registered firms
43 firms currently registered for this product code
Rms Co.
MINNEAPOLIS, MN, US
Surgical Technologies, Inc.
ST. PAUL, MN, US
Phillips Precision Inc
Elmwood Park, NJ, US
Pro-tech Design & Mfg., Inc.
SANTA FE SPRINGS, CA, US
Turnco Tool & Instrument, Inc.
Georgetown, TX, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Orchid Unique
Bridgeport, MI, US
Millstone Medical Outsourcing Llc.
FALL RIVER, MA, US
Paragon Medical, Inc.
PIERCETON, IN, US
Pro-tech Design & Mfg, Inc.
Santa Fe Springs, CA, US
Isomedix Operations, Inc.
Temecula, CA, US
Quality Tech Services, Llc
Bloomington, MN, US
Stryker Gmbh
SELZACH Solothurn, CH
Banister Tool, Inc.
Pflugerville, TX, US
510(k) clearances
16 clearances for this product code
- Aptis Medical, LLCMay 3, 2019
K190599 · Aptis Medical Distal Radio Ulnar Joint Implant
- Aptis Medical, LLCApr 3, 2015
K142569 · Aptis Medical Distal Radio Ulnar Joint Implant
- Ascension OrthopedicApr 9, 2012
K112481 · FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
- Remi Sciences, Inc.Nov 21, 2008
K081025 · ISOELASTICU
- Aptis Medical, LLCOct 24, 2008
K082839 · DISTAL RADIO-ULNAR JOINT IMPLANT
- Small Bone Innovations, Inc.Jul 19, 2006
K061146 · SBI ULNAR HEAD IMPLANT
- Aptis Medical, LLCDec 7, 2005
K053119 · DISTAL RADIO-ULNAR JOINT IMPLANT
- Ascension Orthopedics, Inc.Nov 3, 2005
K052137 · ASCENSION MUH