Implant Direct dental implant recall: Packaging error risk
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.
Lower-risk recall
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/69547-implant-direct-dental-implant-recall-packaging-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69547-implant-direct-dental-implant-recall-packaging-error-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0363-2020
Cite this page
“Implant Direct dental implant recall: Packaging error risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69547-implant-direct-dental-implant-recall-packaging-error-risk. Based on FDA recall #Z-0363-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Implant Direct- Category
Medical device
What to do — step by step
Check Product Details
Verify your implant's model, size, and lot number against the recall information to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 17 states.
FDA distribution: “US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, Arizona, Arkansas, California, Colorado, Florida, Idaho, Illinois, Kansas, Minnesota, Nevada, New York, North Carolina, Ohio, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0363-2020 (October 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0363-2020 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.