Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Legacy"2 HA Implant

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Legacy"2 HA Implant see related information
Date Initiated by Firm August 09, 2019
Date Posted November 12, 2019
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-0364-2020
Recall Event ID 83763
510(K)Number K090234  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA

Dental Implants
Code Information Lot #135128 Exp: 3/12/20
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Elizabeth Dunn
818-444-3300 Ext. 5467
Manufacturer Reason
for Recall		 A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
FDA Determined
Cause 2		 Packaging
Action Implant Direct Sybron Manufacturing LLC mailed out an urgent medical device recall notice on 8/9/2019 to its customers via FedEx overnight priority instructing them to take the following actions: 1. Please review your inventory for the affected product. If located, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within fortyeight (48) hours, whether you have affected product or not. 3. 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 and contact these customers to inform them of this issue within fortyeight (48) hours of receipt. 4.If you have any of the affected product listed above, please return the product and we will send you a replacement part. 5.If you have any questions, please contact Implant Direct Sybron Manufacturing LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 6.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
Quantity in Commerce 23 implants
Distribution U.S.: IN, VA, MD, TX, WA OUS: 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 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
-
-