Home › Ascension Orthopedics, Inc. › Integra®

Integra®

Ascension Orthopedics, Inc. · Model MRADHDINSTP · UDI-DI 10381780235002

KWI Prescription

510(k) clearances

1,793

Adverse events (3 deaths)

Recalls

100

Facilities

Description

The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.