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U.S. Department of Health and Human Services

Class 2 Device Recall NobelActive Internal Connection Implant

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  Class 2 Device Recall NobelActive Internal Connection Implant see related information
Date Initiated by Firm May 28, 2019
Create Date June 03, 2020
Recall Status1 Terminated 3 on February 09, 2021
Recall Number Z-2250-2020
Recall Event ID 85530
510(K)Number K071370  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Code Information Lot 13076845
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715 Savi Ranch Pkwy
Yorba Linda CA 92887-4609
For Additional Information Contact
714-282-4800
Manufacturer Reason
for Recall		 Packaged dental implant healing abutments were found to contain the wrong size device.
FDA Determined
Cause 2		 Labeling mix-ups
Action On 5/28/2019, the firm mailed "Urgent Medical Device Recall" letters with an acknowledgement forms. The letter instructs the customers to: 1. Identify affected devices in your stock. 2. Do not use affected devices. 3. Complete and return the Customer Acknowledgment Form. 4. Return affected devices. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x 1527.
Quantity in Commerce 234 pieces globally, of which 16 were sent to the US.
Distribution Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.
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 = DZE and Original Applicant = NOBEL BIOCARE AB
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