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Align

SKELETAL DYNAMICS L.L.C. · Model ALIGN, Neck Gauge & Head Inserter, 2mm · UDI-DI 00841506100715

KWI Prescription

510(k) clearances

1,793

Adverse events (3 deaths)

Recalls

Facilities

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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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.