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Ascension® Modular Radial Head

Ascension Orthopedics, Inc. · Model MRH35024S · UDI-DI 10381780114529

KWI Prescription
1
510(k) clearances
1,793
Adverse events (3 deaths)
30
Recalls
99
Facilities

Description

Ascension® Modular Radial Head Radial Implant Head

Recalls

DateFirmReason
2022-08-03Wright 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
2022-08-03Wright 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
2022-04-07Synthes (USA) Products LLCDePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyeliti
2020-08-26Wright Medical Technology IncLack of sterility assurance
2019-12-27Wright 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.
2019-12-27Wright 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.
2017-10-24Howmedica 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.
2017-10-24Howmedica 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.
2017-10-24Howmedica 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.
2017-10-24Howmedica 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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Data 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.