Class 2 Device Recall ImplantDirect

• Date Initiated by Firm: September 23, 2021
• Create Date: November 03, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0198-2022
• Recall Event ID: 88859
• 510(K)Number: K192221
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• Product: ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
• Code Information: lot # 166300 / UDI: 10841307101796
• Recalling Firm/ Manufacturer: Implant Direct Sybron Manufacturing LLC; 3050 E Hillcrest Dr; Westlake Village CA 91362-3171
• For Additional Information Contact: Customer Service and Technical Support Team; 888-649-6425
• Manufacturer Reason for Recall: Packaged dental implant contains a different size then the size declared on the labeling.
• FDA Determined Cause: Packaging change control
• Action: On October 11, 2021, Implant Direct issued an "Urgent: Medical Device Recall" Notice via. Mail . In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Please immediately examine, identify, and quarantine the affected product subject to recall (Table-1). 2. If located, immediately return the affected product with the pre-paid shipping label included with the notification letter to us according to the instructions on the attached form. Upon receipt of the returned product a credit will be issued accordingly. 3. Please complete, scan, and email the Acknowledgement Form within forty eight (48) hours of receipt of this notification, whether you have affected product or not, to legacy2implants@implantdirect.com 4. 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 forty eight (48) hours of receipt of this notification. 5. If you have any questions, contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. If you or your patients have 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 Implant Direct Sybron Manufacturing sincerely apologizes for the inconvenience this situation may cause. 6. For Questions Contact: Customer Service and Technical Support team Monday through Friday, 8:00 AM to 4:30 PM, Pacific Time Zone Tel: 888-649-6425 Email: legacy2implants@implantdirect.com
• Quantity in Commerce: 83 implants
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
• 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 = DZE and Original Applicant = Implant Direct Sybron Manufacturing, LLC