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EVOLVE

WRIGHT MEDICAL TECHNOLOGY, INC. · Model 496S275 · UDI-DI 00840420185877

KWI Prescription
10
510(k) clearances
1,793
Adverse events (3 deaths)
30
Recalls
98
Facilities

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.