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U.S. Department of Health and Human Services

Class 2 Device Recall SwishTapered Implant

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  Class 2 Device Recall SwishTapered Implant see related information
Date Initiated by Firm January 19, 2018
Create Date March 22, 2018
Recall Status1 Completed
Recall Number Z-1167-2018
Recall Event ID 79396
510(K)Number K090234  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product SwishTapered Implant

Intended for use in support for fixed bridgework.
Code Information Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077).
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact
818-444-3300
Manufacturer Reason
for Recall		 The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
FDA Determined
Cause 2		 Process control
Action Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in Commerce 1,117 units total
Distribution Worldwide Distribution -- US, Europe, Canada, Australia, and 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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = IMPLANT DIRECT LLC
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