Date Initiated by Firm |
February 26, 2019 |
Create Date |
August 02, 2019 |
Recall Status1 |
Terminated 3 on June 15, 2020 |
Recall Number |
Z-2140-2019 |
Recall Event ID |
82263 |
510(K)Number |
K052648 K102209
|
Product Classification |
Abutment, implant, dental, endosseous - Product Code NHA
|
Product |
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - 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: 8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1 |
Recalling Firm/ Manufacturer |
Biomet 3i, LLC 4555 Riverside Dr Palm Beach Gardens FL 33410-4200
|
For Additional Information Contact |
Zimmer 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 |
Action |
The 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 Commerce |
3 units |
Distribution |
Nationwide and Puerto Rico, Canada, and Australia |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = NHA and Original Applicant = BIOMET 3I, INC. 510(K)s with Product Code = NHA and Original Applicant = IMPLANT INNOVATIONS, INC.
|