Implant Direct dental implants: Cap mislabeled part number

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Contact the company & request your remedy

Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Thousand Oaks, CA 91362

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Implant Direct is recalling dental implants that may have mislabeled caps. The correct part number is on the main vial label, so this doesn't pose a safety risk.

Why it’s dangerous

The cap may have an incorrect part number, but the correct part number is on the main vial label. This could cause confusion during dental procedures but doesn't pose a safety risk.

Who’s affected

Dental professionals using Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform implants. Patients using these implants for temporary impressions are most at risk.

How to tell if you have this one

Check for part number 8735-05 and lot number 90212 on the main vial label. The product was sold as a dental implant component used temporarily during impressions.

Brand
Implant Direct
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cap Label
Verify the part number on the main vial label matches the correct part number (8735-05).

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

No, the recall is for potential mislabeling but does not pose a safety risk.

What should I do if I have this product?

Check the main vial label for the correct part number (8735-05). No action is needed if the label matches.

How can I tell if I have the recalled product?

Look for part number 8735-05 and lot number 90212 on the main vial label.

Take action

Contact Implant Direct

We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0089-2019 — Implant Direct Implant Direct

Hello,

I own a Implant Direct that is covered by recall Z-0089-2019 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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Where this comes from

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.

Official source: FDA Recall #Z-0089-2019 (May 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0089-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used

Lower-risk recall