Home › Device types › KWI
Prosthesis, Elbow, Hemi-, Radial, Polymer
FDA product code KWI · Class 2 · Orthopedic
869
Registered devices
1,793
Adverse events
30
Recalls
34
510(k) clearances
Devices with this code
SOLAR — Howmedica Osteonics Corp.Modular Radial Head (MRH) System — Smith & Nephew, Inc.Align — SKELETAL DYNAMICS L.L.C.ACUMED — Acumed LLCACUMED — Acumed LLCCD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.RHEAD — Stryker GmbHACUMED — Acumed LLCAvenger — In2Bones USA, LLCAvenger — In2Bones USA, LLCBioPoly® Radial Head Implant — Biopoly, LLCAvenger — In2Bones USA, LLCAvenger — In2Bones USA, LLCRHS - RADIAL PROSTHESIS — TORNIERACUMED — Acumed LLCACUMED — Acumed LLCRHS - RADIAL PROSTHESIS — TORNIEREXPLOR — Biomet Orthopedics, LLCACUMED — Acumed LLCACUMED — Acumed LLCSWANSON — WRIGHT MEDICAL TECHNOLOGY, INC.Align — SKELETAL DYNAMICS L.L.C.Avenger — In2Bones USA, LLCACUMED — Acumed LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-03 | Wright Medical Technology, Inc. | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected |
| 2022-08-03 | Wright Medical Technology, Inc. | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected |
| 2022-04-07 | Synthes (USA) Products LLC | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, |
| 2020-08-26 | Wright Medical Technology Inc | Lack of sterility assurance |
| 2019-12-27 | Wright Medical Technology, Inc. | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product |
| 2019-12-27 | Wright Medical Technology, Inc. | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product |
| 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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