ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-u...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2551-2018.
The main vial label lists the incorrect part number, but the cap label is correct.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2551-2018.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Implant Direct Sybron Manufacturing, Llc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2551-2018.
Implant Direct Sybron Manufacturing, LLC
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Implant Direct Sybron Manufacturing, Llc Recall FAQ
Implant Direct Sybron Manufacturing, Llc is the subject of a medical implants safety report: ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-u.... The notice was published on March 3, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 124 units are potentially affected.