Class 2 Device Recall Swish DuoGrip Healing Collar

• Date Initiated by Firm: July 21, 2017
• Create Date: October 03, 2017
• Recall Status: Terminated 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/ Manufacturer: Implant Direct Sybron Manufacturing, LLC; 3050 E Hillcrest Dr; Westlake Village CA 91362-3171
• For Additional Information Contact: Customer Care; 888-649-6425
• 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: 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