Integra recalls 12mm bioBLOCK resorbable subtalar implants with temperature indicator that may turn dark gray/black before shipment, indicating exposure to high temperatures.
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
Integra is recalling 12mm bioBLOCK resorbable subtalar implants that may have changed color to dark gray or black due to exposure to temperatures above 110°F during shipping. This could mean the implants are unsafe for use as they might not function properly in the body.
The temperature indicator on the implant may change color to dark gray or black if the product was exposed to temperatures above 110°F during shipping. This change indicates the implant might not be safe for use in the body as it could fail to provide proper support.
Patients who received the Integra bioBLOCK 12mm implant with catalog number 040012 and lot number FGD8329 are affected. Orthopedic surgeons and patients using this implant for flatfoot treatment are most at risk.
Check for the 12mm bioBLOCK resorbable subtalar implant with catalog number 040012 and lot number FGD8329. The temperature indicator may show dark gray or black color if exposed to high temperatures.
Look for dark gray or black color on the temperature indicator, which may indicate exposure to high temperatures.
The temperature indicator may have changed color to dark gray or black before shipment, indicating exposure to temperatures greater than 110°F.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates the implant may not be safe if the temperature indicator shows dark gray or black color due to exposure to high temperatures.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1091-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1091-2019 from Integra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
