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U.S. Department of Health and Human Services

Class 2 Device Recall ImplantDirect simply RePlant Implant

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  Class 2 Device Recall ImplantDirect simply RePlant Implant see related information
Date Initiated by Firm August 07, 2018
Create Date October 01, 2019
Recall Status1 Terminated 3
Recall Number Z-0010-2020
Recall Event ID 83086
510(K)Number K061319  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Code Information Lot 108191, UDI (01)10841307108313(17)230118(10)108191
Recalling Firm/
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Elizabeth Dunn
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall
The incorrect device was packaged in the vial.
FDA Determined
Cause 2
Employee error
Action The recalling firm issued letters dated 8/7/2018 via FedEx or email on 8/7/2018 informing the consignee of the issue and requesting they review their inventory for the affected product and quarantine it until it is returned.
Quantity in Commerce 158 devices
Distribution Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
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