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U.S. Department of Health and Human Services

Class 2 Device Recall Swish DuoGrip Healing Collar

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  Class 2 Device Recall Swish DuoGrip Healing Collar see related information
Date Initiated by Firm July 21, 2017
Create Date October 03, 2017
Recall Status1 Terminated 3 on April 01, 2021
Recall Number Z-0007-2018
Recall Event ID 77788
510(K)Number K090234  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Code Information Product Code 9048-13H, Lot No. 81080
Recalling Firm/
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Customer Care
Manufacturer Reason
for Recall
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
FDA Determined
Cause 2
Employee error
Action Recall notification letters were sent to consignees, via mail on 07/21/2107. Instructions included to review current inventory and remove affected product, to complete and return the Acknowledgement and Recall Return form, and to notify customers who received product if it was further distributed.
Quantity in Commerce 50 units
Distribution Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
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 = IMPLANT DIRECT LLC