FDA recall Z-1091-2019

Integra Limited · Class II · device

Product

Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.

Reason for recall

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

Distribution

US Nationwide distribution in the states of OH, MI.

Key facts

Status
Terminated
Initiation date
2019-03-01
Report date
2019-04-17
Termination date
2020-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1091-2019