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U.S. Department of Health and Human Services

Class 2 Device Recall BIOMET 3i LTX DENTAL IMPLANTS

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  Class 2 Device Recall BIOMET 3i LTX DENTAL IMPLANTS see related information
Date Initiated by Firm March 08, 2017
Create Date March 29, 2017
Recall Status1 Terminated 3 on August 02, 2019
Recall Number Z-1701-2017
Recall Event ID 76809
510(K)Number K063286  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product BIOMET 3i LTX DENTAL IMPLANTS
Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Code Information LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Customer Service
800-342-5454
Manufacturer Reason
for Recall		 A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
FDA Determined
Cause 2		 Under Investigation by firm
Action On March 13 Zimmer Biomet contacted their international consignee and asked them to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form. a. Return a digital copy to postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship within your territory along with a completed Attachment 1  Inventory Return Certification Form to Biomet 3i. a. For each return, send a copy of Attachment 1 to postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returns box(es) clearly with RECALL. 5. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. If after reviewing this notice you have further questions or concerns please contact us by email at postmarket@zimmerbiomet.com. 1-800-342-5454
Quantity in Commerce 5
Distribution Argentina
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 INNOVATIONS, INC.
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