Integra recalls 11mm bioBLOCK resorbable subtalar implants with temperature indicator that may turn dark gray, indicating exposure to temperatures above 110°F.
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 11mm bioBLOCK resorbable subtalar implants that may have a temperature indicator turning dark gray due to exposure to temperatures above 110°F. This could affect the implant's safety and effectiveness.
The temperature indicator may change color to dark gray or black if the implant was exposed to temperatures above 110°F during shipping or storage. This could indicate improper temperature control during manufacturing or handling, potentially affecting the implant's safety and effectiveness.
Patients who received the Integra bioBLOCK 11mm implant with lot numbers FGD2096 or FGD8328 are likely affected. Those with flatfoot surgery using this implant are at risk.
Check for the product name 'bioBLOCK Resorbable subtalar Implant, 11mm' with catalog number 040011. Look for lot numbers FGD2096 or FGD8328 on the packaging.
Look for a dark gray or black color change on the temperature indicator.
The temperature indicator shows if the implant was exposed to temperatures above 110°F during shipping or storage.
The recall record does not specify actions for this condition.
Lot numbers FGD2096 and FGD8328.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1090-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1090-2019 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.
