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U.S. Department of Health and Human Services

Class 2 Device Recall CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM

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 Class 2 Device Recall CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MMsee related information
Date Initiated by FirmFebruary 26, 2019
Create DateAugust 02, 2019
Recall Status1 Terminated 3 on June 15, 2020
Recall NumberZ-2141-2019
Recall Event ID 82263
510(K)NumberK052648 K102209 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductCERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Code Information 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 
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information ContactZimmer Biomet, Customer Service
888-800-8045
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionThe firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.
Quantity in Commerce17 units
DistributionNationwide and Puerto Rico, Canada, and Australia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NHA
510(K)s with Product Code = NHA
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