Integra Limited recalls Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indi…

Recall date

March 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1090-2019

FDA classification

Class II

Brand / firm

Integra Limited

Sold / distributed

US Nationwide distribution in the states of OH, MI.

Why it was recalled

Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.