Implant Direct recalls a specific Interactive Healing Collar model due to improper sterilization before labeling as sterile. Affected units may pose infection risks if used.
InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Implant Direct is recalling a specific Interactive Healing Collar model because it was distributed before being properly sterilized. This could lead to infection risks if the device is used without proper sterilization.
The device was labeled as sterile but distributed before completing the sterilization process. This means the device may not be sterile when used, potentially leading to infections.
Users of the specific Interactive Healing Collar model with Lot Number 104203 are affected. Patients using this device for medical purposes may be at risk of infection if the device is not properly sterilized.
Check for the product name 'Interactive Healing Collar', part number 6530-15, and lot number 104203. The device is a 5.0mmL: 3.0mmD Platform model.
Identify the product name, part number, and lot number to confirm if it matches the recalled item.
The device was labeled as sterile but distributed before sterilization was complete, so it may not be sterile when used. This could pose infection risks.
The recall does not specify a remedy, so check the product details to confirm if it matches the recalled item.
Look for the product name 'Interactive Healing Collar', part number 6530-15, and lot number 104203.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-0539-2018 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-0539-2018 from Implant Direct. 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.
