The Recall Desk

FDA (Devices) recall action 82361

Integra Limited recalled 3 products on 2019-04-17

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-04-17
Critical
0
Units
696

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.

    Product
    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.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.

    Product
    Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.

    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.
    Category
    Distribution
    2 states