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
|