ImplantDirect Legacy 3 Implant (13mm L, REF 864713) recalled due to potential sterilization compromise from improper cap sealing. Affected units sold with lot number 79607.
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
The U.S. government has recalled ImplantDirect Legacy 3 Implant (13mm L, REF 864713) because the outer vial may be undersized, risking improper cap sealing and sterilization compromise. This could lead to infection or contamination during dental procedures.
The outer vial may be out of round and undersized, causing the inner vial and components to not slide out freely. This could prevent the cap from screwing on properly, compromising sterilization.
Dental patients who received this specific implant during surgery are most at risk. The recall applies to units with lot number 79607.
Check for the product name 'Legacy 3 Implant', size 13mm L, and reference number 864713. Affected units were sold with lot number 79607.
Verify the product name, size, reference number, and lot number to confirm if it's affected.
The recall indicates a potential risk of sterilization compromise, so it's not recommended for use until the remedy is applied.
Check the product details to confirm if it's affected; if yes, contact the manufacturer for guidance.
Look for the product name 'Legacy 3 Implant', size 13mm L, reference number 864713, and lot number 79607.
We’ve drafted a message you can send ImplantDirect to request your refund or repair — edit it as you like.
Subject: Recall Z-0185-2018 — ImplantDirect ImplantDirect Hello, I own a ImplantDirect that is covered by recall Z-0185-2018 from ImplantDirect. 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.
