CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2141-2019.
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2141-2019.
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 Biomet 3i, 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-2141-2019.
Biomet 3i, 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.
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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.
Biomet 3i, Llc Recall FAQ
Biomet 3i, Llc is the subject of a medical implants safety report: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as.... The notice was published on February 26, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 17 units are potentially affected.