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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 December 12, 2016
Date Posted January 28, 2017
Recall Status1 Terminated 3 on May 22, 2017
Recall Number Z-1112-2017
Recall Event ID 76111
510(K)Number K090234  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product SwishTapered Implant
Code Information 933308 Lot # 73241
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact
818-444-3300 Ext. 3323
Manufacturer Reason
for Recall		 The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
FDA Determined
Cause 2		 Packaging process control
Action Customer notification letters were sent on 12/12/16. Customers were requested to review inventory for the affected product. Complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized distributor the firm requests that they identify those customers that may have been shipped the affected product lot and contact those customers to inform them of the issue within 48 hours of receipt of the notification in order to provide the customers with replacement product. If customers have any of the affected product the firm will send a replacement part. Any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in Commerce 17
Distribution U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
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
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