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U.S. Department of Health and Human Services

Class 2 Device Recall Legacy 4 Implant

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  Class 2 Device Recall Legacy 4 Implant see related information
Date Initiated by Firm November 15, 2016
Create Date May 23, 2018
Recall Status1 Terminated 3 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/
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 2
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