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U.S. Department of Health and Human Services

Class 2 Device Recall SMARTbase Nonengaging Abutments

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  Class 2 Device Recall SMARTbase Nonengaging Abutments see related information
Date Initiated by Firm May 02, 2023
Date Posted June 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-2037-2023
Recall Event ID 92415
510(K)Number K223535  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE;
LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE;
LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE;
LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE
LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE;
LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
Code Information REF/UDI-DI/Lot: 8730-81NE/10841307123002/92637, 131309; 8730-82NE/10841307123019/92638, 163063; 8735-80NNE/10841307123026/160542; 8735-82NE/10841307123064/15002360; 8745-80NNE/10841307123033/15004780; 8745-82NE/10841307123071/182029;
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact
818-444-3300
Manufacturer Reason
for Recall		 Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
FDA Determined
Cause 2		 No Marketing Application
Action On 5/2/23, correction notices were emailed to customers who were asked to do the following: 1) Contact recalling firm to arrange return of affected product that has not yet been placed in the patient. 2) Share this notice with those who need to be aware within your organization and any organization where the potentially affected devices have been transferred. 3) Complete and return the acknowledgement form to Questions, complaints, or adverse events can be reported to the recalling firm via phone 1-888-649-6425 (Monday - Friday, 5AM - 5PM PST) or through their website: https://www.implantdirect.com/en-us
Quantity in Commerce 29
Distribution US Nationwide distribution in the states of FL, ID, TX, CA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NHA and Original Applicant = Implant Direct Sybron Manufacturing LLC
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