Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Orthopedic · 21 CFR 888.3660
Replacement of the humeral head for total anatomic shoulder arthroplasty
Recent MDR events
343 adverse event reports on file
- GLOBAL ICONJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13079
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00762
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00766
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00765
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00767
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00769
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00768
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00764
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00763
- Unk Simpliciti implantsJul 28, 2026InjuryTornier Inc0001649390-2026-00771
Event type breakdown
Recalls
3 recall events for this product code
- Tornier, IncOpen, ClassifiedSep 16, 2024
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Z-3155-2024 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0300-2020 · View FDA record ↗ - Zimmer GmbHTerminatedUnknown
Sidus Stem-Free Shoulder Humeral Head 50-18
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Z-2762-2019 · View FDA record ↗
Registered firms
134 firms currently registered for this product code
Sterigenics Us Llc
Fort Worth, TX, US
Encore Medical, L.p.
AUSTIN, TX, US
Shoulder Innovations, Inc
Grand Rapids, MI, US
Turnco Tool & Instrument, Inc.
Georgetown, TX, US
Perryman Company
Houston, PA, US
Depuy Ireland Uc
Co. Cork Munster, IE
Sterigenics Us Llc
Gurnee, IL, US
Tornier Inc.
Columbia City, IN, US
Fx Shoulder Solutions Sas
Viriat Auvergne-Rhone-Alpes, FR
Smith & Nephew, Inc.
MEMPHIS, TN, US
Smb Medical Sa
Sant'Antonino Ticino, CH
Ionisos
Dagneux Ain, FR
Aps Materials, Inc.
DAYTON, OH, US
Arthrex Australia Pty Ltd.
Frenchs Forest New South Wales, AU
Arthrex Singapore Pte Ltd.
Singapore Central Singapore, SG
Arthrex New Zealand Limited
Auckland, NZ
Sterigenics Us, Llc
Lewis Center, OH, US
Zimmer, Inc.
WARSAW, IN, US
Tornier S.a.s.
Montbonnot Saint-Martin Isere, FR
Gb Implantat Technologie Gmbh
Bochum North Rhine-Westphalia, DE
Isomedix Operations Inc.
Northborough, MA, US
510(k) clearances
19 clearances for this product code
- FX Shoulder Solutions, Inc.May 1, 2026
K254154 · FX V135 EASYTECH® Shoulder System
- Smith & Nephew, Inc.Oct 3, 2025
K252129 · AETOS Shoulder System Stemless Humeral Prosthesis
- Depuy Ireland UCDec 23, 2024
K243248 · INHANCE INTACT
- Zimmer, Inc.Dec 11, 2024
K241873 · OsseoFit Stemless Shoulder System
- Smith & Nephew, Inc.Nov 20, 2024
K240716 · AETOS Shoulder System Stemless Humeral Prosthesis
- Lima Corporate S.P.A.Mar 17, 2023
K221758 · SMR Stemless Anatomic
- Tornier, Inc.Sep 14, 2022
K220418 · Tornier Perform Humeral System Stemless
- Shoulder Innovations, Inc.Mar 11, 2022
K213615 · Shoulder Innovations Total Shoulder System