KWJClass IIIImplant
Prosthesis, Elbow, Hemi-, Humeral, Metal
Orthopedic · 21 CFR 888.3180
call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
MDR events28All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
28 adverse event reports on file
- MINIMALLY INVASIVE GROWER (MIG)Mar 6, 2026MalfunctionOnkos Surgical3013450937-2026-00106
- UNKNOWN OSTEONICS ULNAR COMPONENTOct 28, 2025InjuryStryker Orthopaedics-mahwah0002249697-2025-01224
- UNKNOWN PROSTHESIS, ELBOW, HEMI-, HUMERAL, METALOct 28, 2025InjuryStryker Orthopaedics-mahwah0002249697-2025-01237
- UNKNOWN OSTEONICS ULNAR STEMOct 27, 2025InjuryStryker Orthopaedics-mahwah0002249697-2025-01220
- TOTAL ELBOW REPLACEMENT WITH FLEXI-HINGESep 19, 2025InjuryOnkos Surgical3013450937-2025-00229
- UNKNOWN SOLAR ELBOW HUMERAL COMPONENTOct 31, 2022InjuryStryker Orthopaedics-mahwah0002249697-2022-01574
- UNKNOWN DISCOVERY ELBOW- HUMERUSOct 24, 2022InjuryZimmer Biomet, Inc.0001825034-2022-02400
- UNKNOWN DISCOVERY ELBOW- BEARINGOct 24, 2022InjuryZimmer Biomet, Inc.0001825034-2022-02401
- UNKNOWN DISCOVERY ELBOW- ULNAOct 24, 2022InjuryZimmer Biomet, Inc.0001825034-2022-02402
- UNKNOWN HUMERALFeb 8, 2022InjuryZimmer Biomet, Inc.0001822565-2022-00384
Event type breakdown
Injury24
Malfunction2
Unspecified1
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.