Home › Ascension Orthopedics, Inc. › Katalyst™ Bipolar Radial Head System
Katalyst™ Bipolar Radial Head System
Ascension Orthopedics, Inc. · Model 221418 · UDI-DI 10381780065784
KWI
Prescription
1
510(k) clearances
1,793
Adverse events (3 deaths)
30
Recalls
99
Facilities
Description
The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation.
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 lot of EVOLVE Proli |
| 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 lot of EVOLVE Proli |
| 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, sepsis, osteomyeliti |
| 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 post-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 post-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 post-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 post-surgery. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.