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Integra®

Ascension Orthopedics, Inc. · Model CGT-50T · UDI-DI 10381780257646

KWH Prescription

510(k) clearances

149

Adverse events

Recalls

Facilities

Description

CGT Implant Size 50 The Classic Flexible Great Toe implant is a third generation prosthesis designed to supplement first metatarsophalangeal joint arthroplasty. Constructed from medical grade silicone elastomer, the Classic offers a patented axial offset hinge and other advanced design features while maintaining the surgical technique of the previous generation joint replacements

Recalls

Date	Firm	Reason
2009-04-06	Tornier, Inc.	Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the
2009-03-01	Sgarlato Med, LLC	Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The o

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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.