Integra recalls 10mm 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 10mm bioBLOCK resorb:orbable 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 turn dark gray or black if it was exposed to temperatures above 110°F during shipping. This change could mean the implant is not safe for use in the body as it might not function properly.
Orthopedic surgeons and patients who received the Integra bioBLOCK 10mm implant with catalog number 40010 and lot number FGD8327 are affected. Those who used the implant in flatfoot surgery are most at risk.
Check for the product name 'bioBLOCK Resorbable subtalar Implant', size 10mm, catalog number 40010, and lot number FGD8327. The temperature indicator may show dark gray or black color.
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.
Check the temperature indicator for dark gray or black color. If it has changed, contact Integra Limited for further instructions.
The implant may not be safe if the temperature indicator has changed color to dark gray or black, as it could indicate 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-1089-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1089-2019 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.
