Home › Device types › JDB
Prosthesis, Elbow, Semi-Constrained, Cemented
FDA product code JDB · Class 2 · Orthopedic
476
Registered devices
704
Adverse events
26
Recalls
27
510(k) clearances
Devices with this code
LATITUDE EV™ — TORNIER, INC.UNI-ELBOW — Stryker GmbHTEMA Elbow — LIMACORPORATE SPATEMA Elbow — LIMACORPORATE SPALatitude™ EV — TORNIER, INC.Latitude™ - Elbow — TORNIER, INC.Latitude™ - Elbow — TORNIER, INC.Latitude™ - Elbow — TORNIER, INC.TEMA Elbow — LIMACORPORATE SPAAMK — DEPUY ORTHOPAEDICS, INC.RHS - RADIAL PROSTHESIS — TORNIERSALTO TALARIS — TORNIERTEMA Elbow — LIMACORPORATE SPATEMA Elbow — LIMACORPORATE SPATEMA Elbow — LIMACORPORATE SPADURALOC — DEPUY ORTHOPAEDICS, INC.TEMA Elbow — LIMACORPORATE SPATEMA Elbow System — LIMACORPORATE SPAUNI-ELBOW — Stryker GmbHLatitude™ EV — TORNIER, INC.TEMA Elbow — LIMACORPORATE SPALatitude™ - Elbow — TORNIER, INC.ELITE — DEPUY INTERNATIONAL LTDRHEAD — Stryker GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-03 | Tornier, Inc | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow co |
| 2024-10-02 | Limacorporate S.p.A | Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
| 2017-10-24 | Howmedica Osteonics Corp. | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level pos |
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