Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for inter...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1090-2019.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1090-2019.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Integra Limited or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1090-2019.
Integra Limited
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Integra Limited Recall FAQ
Integra Limited is the subject of a medical implants safety report: Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for inter.... The notice was published on March 1, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 232 units are potentially affected.