Reported Aug 14, 2019 · Terminated
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are…
Biomet 3i, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet 3i, LLC · 4555 Riverside Dr · Palm Beach Gardens, FL · 33410-4200
Is this the product you have?
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM
- Item Number IIAT3 - Product UsageBIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Lot codes and dates
- Lot Numbers/UDI8441907-1/(01)00844868031284(10)8441907-1 8441907-2/(01)00844868031284(10)8441907-2 8441907-3/(01)00844868031284(10)8441907-3 8442367-1/(01)00844868031284(10)8442367-1 8439134A-3/(01)00844868031284(10)8439134A-3 8439134A-4/(01)00844868031284(10)8439134A-4
- Amount recalled
- 6 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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