Certain(r) Bellatek(r) Titanium Abutment 3.4mm recall
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory…
Why was Certain(r) Bellatek(r) Titanium Abutment 3.4mm 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers/UDI: 8442191-1/(01)00844868031178(10)8442191-1 8442751-1/(01)00844868031178(10)8442751-1 8441857-1/(01)00844868031178(10)8441857-1 8442548-1/(01)00844868031178(10)8442548-1 8442504-1/(01)00844868031178(10)8442504-1 8442556-1/(01)00844868031178(10)8442556-1 8442556-2/(01)00844868031178(10)8442556-2 8442556-3/(01)00844868031178(10)8442556-3 8442556-4/(01)00844868031178(10)8442556-4 8443047-1/(01)00844868031178(10)8443047-1 8443059-1/(01)00844868031178(10)8443059-1 8443071-2/(01)00844868031178(10)8443071-2 8443071-3/(01)00844868031178(10)8443071-3 8443085-1/(01)00844868031178(10)8443085-1 8442164-1/(01)00844868031178(10)8442164-1 8443036-1/(01)00844868031178(10)8443036-1 8443036-2/(01)00844868031178(10)8443036-2
- Product
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory…
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 17 units
- Distribution
- Nationwide and Puerto Rico, Canada, and Australia
- Recall date
- August 14, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)