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U.S. Department of Health and Human Services

Class 2 Device Recall RePlant Precision IO Scan Adapter

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  Class 2 Device Recall RePlant Precision IO Scan Adapter see related information
Date Initiated by Firm September 06, 2018
Create Date October 31, 2019
Recall Status1 Terminated 3 on July 01, 2021
Recall Number Z-0261-2020
Recall Event ID 83573
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
Code Information Part numbers/Lot Numbers: 6035-09PT/Lot # 104539; 6043-09PT/ Lot # 104540; 6050-09PT/Lot # 104511
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Elizabeth Dunn
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall		 The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On X/xx/xxx, consignees were mailed a "Urgent: Medical Device Recall" letter via XXX. The recall notification asked customers to do the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification. 4. If you have any of the affected product, please return the product and we will send you a replacement part. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 5.If you or your patients has experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Quantity in Commerce 107 Scan Adapters
Distribution US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, 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.
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