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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NHA 510(K)s with Product Code = NHA
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