Class 2 Device Recall Legacy 4 Implant

• Date Initiated by Firm: November 15, 2016
• Create Date: May 23, 2018
• Recall Status: Terminated on June 04, 2018
• Recall Number: Z-1920-2018
• Recall Event ID: 79885
• 510(K)Number: K090234
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• Product: ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
• Code Information: Lot #71729
• Recalling Firm/ Manufacturer: Implant Direct Sybron Manufacturing, LLC; 3050 E Hillcrest Dr; Westlake Village CA 91362-3171
• For Additional Information Contact: Mr. Jose Trejo; 818-444-3300 Ext. 3543
• Manufacturer Reason for Recall: The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
• FDA Determined Cause: Labeling mix-ups
• Action: Letters dated 11/14/2016 were issued via FedEx overnight on 11/15/2016.
• Quantity in Commerce: 18 units
• Distribution: Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
• 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 = DZE and Original Applicant = IMPLANT DIRECT LLC