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Integra® MOVEMENT® Great Toe System

Ascension Orthopedics, Inc. · Model MGT89020PPT · UDI-DI 10381780119906

LZJ Prescription
1
510(k) clearances
79
Adverse events
1
Recalls
9
Facilities

Description

The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.

Recalls

DateFirmReason
2014-06-09Arthrosurface, Inc.An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

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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.