ImplantDirect simply RePlant Implant: Incorrect Packaging Risk
ImplantDirect recalls a specific size 4.3mmD x 13mmL implant due to incorrect packaging in vials. Affected units have a specific lot number and label details. Consumers should contact the manufacturer for guidance.
Lower-risk recall
The incorrect device was packaged in the vial.
Contact the company
What happened, in plain English
ImplantDirect is recalling a specific size 4.3mmD x 13mmL RePlant implant because it was packaged incorrectly in vials. This could lead to improper use if the wrong implant is used during medical procedures. Read more at govinfonow.com/recall/70182-implantdirect-simply-replant-implant-incorrect-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/70182-implantdirect-simply-replant-implant-incorrect-packaging-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0010-2020
Cite this page
“ImplantDirect simply RePlant Implant: Incorrect Packaging Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70182-implantdirect-simply-replant-implant-incorrect-packaging-risk. Based on FDA recall #Z-0010-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0010-2020%22&limit=1).
Why it’s dangerous
The implant was packaged incorrectly in vials, which could mean the wrong implant is used during medical procedures. This might lead to improper treatment if the incorrect device is implanted.
Who’s affected
Patients who received this specific implant size and lot number from the manufacturer. Medical professionals using this implant for procedures are at risk of using the incorrect device.
How to tell if you have this one
Check the label for the firm name 'Implant Direct Sybron Manufacturing LLC' and lot number 108191. The product has a specific reference number REF 604313U and is sterile.
- Brand
Implant Direct- Product
Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm…- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Implant Direct Sybron Manufacturing LLC for guidance on whether the implant is affected.
Where it went and when
Where it was distributed
Distributed in 17 states, and outside the U.S.
FDA distribution: “Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Massachusetts, Nevada, New Mexico, New York, Pennsylvania, Texas.
Recall timeline
FDA published this recall 14 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-0010-2020 (August 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0010-2020 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.