Prosthesis, Wrist, Carpal Trapezium
Orthopedic · 21 CFR 888.3770
Recent MDR events
345 adverse event reports on file
- STABLYX CMC ARTHROPLASTY SYSTEMJul 16, 2026InjurySkeletal Dynamics, IncMW5190813
- SKELETAL DYNAMICSJun 12, 2026MalfunctionSkeletal Dynamics Inc.3006742481-2026-00012
- BIOPRO MODULAR THUMB IMPLANTMay 4, 2026InjuryBiopro Inc.MW5187631
- NUGRIP SZ. 30LFeb 26, 2024InjuryAscension Orthopedics, Inc.3002788818-2024-00025
- SKELETAL DYNAMICSJul 29, 2020InjurySkeletal Dynamics3006742481-2020-00007
- UNKNOWN CARPAL BALLApr 20, 2020InjuryStryker Gmbh0008031020-2020-01363
- UNKNOWN RADIAL STEMApr 20, 2020InjuryStryker Gmbh0008031020-2020-01361
- UNKNOWN RADIAL STEMApr 20, 2020InjuryStryker Gmbh0008031020-2020-01366
- UNKNOWN CARPAL BALLApr 20, 2020InjuryStryker Gmbh0008031020-2020-01371
- UNKNOWN RADIAL STEMApr 16, 2020InjuryStryker Gmbh0008031020-2020-01319
Event type breakdown
Recalls
5 recall events for this product code
- Integra LifeSciences Corp.TerminatedJun 21, 2013
CMC Saddle
As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.
Z-1568-2013 · View FDA record ↗ - Ascension Orthopedics, IncTerminatedNov 22, 2010
The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis fo
Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
Z-0437-2011 · View FDA record ↗ - Ascension Orthopedics, IncTerminatedNov 22, 2010
The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis fo
Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
Z-0438-2011 · View FDA record ↗ - Avanta Orthopaedics, Inc.TerminatedApr 9, 2003
Finger Joint Implants, Silicone
Wrong silicone elastomer used in construction.
Z-0710-03 · View FDA record ↗ - Wright Medical Technology, Inc.TerminatedUnknown
SWANSON TRAPEZIUM IMPLANT, Part Number 4520002
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Z-0572-2020 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
On-x Life Technologies Inc.
Austin, TX, US
Tornier S.a.s.
Montbonnot Saint-Martin Isere, FR
Tornier, Inc.
Bloomington, MN, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Tornier, Sas
GRENOBLE CEDEX 1 Isere, FR
Structure Medical, Llc.
Naples, FL, US
Banister Tool, Inc.
Pflugerville, TX, US
Skeletal Dynamics, Inc
Miami, FL, US
Biopro, Inc.
PORT HURON, MI, US
Millstone Medical Outsourcing Llc.
FALL RIVER, MA, US
Hnm Medical Dba Hnm Total Recon
Miami, FL, US
Structure Medical, Llc.
Mooresville, NC, US
Lynx Medical Nj
Franklin, NJ, US
Quality Tech Services, Llc
Bloomington, MN, US
Wright Medical Technology, Inc.
Arlington, TN, US
Ionisos
SABLE-SUR-SARTHE, FR
Rms Co.
MINNEAPOLIS, MN, US
510(k) clearances
26 clearances for this product code
- Ensemble Orthopedics, LLCDec 2, 2020
K201072 · Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
- Skeletal Dynamics, LLCApr 11, 2018
K180744 · Stablyx CMC Arthroplasty Implant System
- Skeletal Dynamics, LLCDec 30, 2011
K111068 · STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
- Ascension OrthopedicNov 4, 2011
K112278 · ASCENSION NUGRIP CMC IMPLANT
- Extremity Medical, LLCDec 15, 2009
K092548 · EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
- Artimplant ABJun 7, 2007
K061956 · ARTELON STT SPACER
- Artimplant ABJun 1, 2007
K061954 · ARTELON CMC SPACER ARTHRO
- Ascension Orthopedics, Inc.Aug 11, 2006
K061451 · ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40