Implant Direct recalls specific dental implants due to possible packaging error with incorrect healing collar. Affected units include REF654311U, SBM surface, 4.3mmD x 11.5mmL, sterile. No remedy stated in official notice.
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Implant Direct is recalling a specific dental implant model (REF654311U) because a packaging error might have included an incorrect healing collar. This could affect the implant's proper function during healing.
A packaging error during quality control could have included an incorrect healing collar in the implant assembly kit. This might lead to improper healing if the wrong collar is used with the implant.
Dental patients who own or use the specific Implant Direct dental implant model REF654311U with SBM surface, 4.3mmD x 11.5mmL size. Patients with this implant are most at risk.
Check for the product code REF654311U, SBM surface, 4.3mmD x 11.5mmL, and sterile packaging. Lot numbers 120197 (expiring 07/16/2023) or 120198 (expiring 07/19/2023) are also indicators.
Verify your implant's model, size, and lot number against the recall information to confirm if it's affected.
The recall is due to a possible packaging error, not a defect in the implant itself. If used correctly with the right healing collar, it should be safe.
The official notice does not specify a remedy, so contact your dentist or the manufacturer for guidance.
Check for the model REF654311U, SBM surface, 4.3mmD x 11.5mmL, and lot numbers 120197 or 120198.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-0363-2020 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-0363-2020 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.
