Integra Limited: Medical Device Recall in 2019 - (Recall #: Z-1091-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 1, 2019

Date Posted: April 17, 2019

Recall Number: Z-1091-2019

Event ID: 82361

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

Status: Terminated

Product Quantity: 232 total

Code Information:

Lot Number: FGD8329

Distribution Pattern:

US Nationwide distribution in the states of OH, MI.

Voluntary or Mandated:

Voluntary: Firm initiated