Date Initiated by Firm | October 10, 2017 |
Create Date | November 29, 2017 |
Recall Status1 |
Terminated 3 on September 27, 2018 |
Recall Number | Z-0185-2018 |
Recall Event ID |
78350 |
510(K)Number | K090234 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product | ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713
This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. |
Code Information |
Lot Number: 79607 |
Recalling Firm/ Manufacturer |
Implant Direct Sybron Manufacturing, LLC 3050 E Hillcrest Dr Westlake Village CA 91362-3171
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For Additional Information Contact | Customer Care Team 888-649-6425 |
Manufacturer Reason for Recall | One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised. |
FDA Determined Cause 2 | Process design |
Action | The firm, Implant Direct Sybron Manufacturing, LLC, sent an "URGENT: Safety Alert/Advisory Notice" letter to its distributors/customers on 10/10/2017.
Distributors were instructed as follows:
"1. Please review your inventory for the affected product.
2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours.
3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product."
Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Customers were instructed as follows:
"1. Please review your inventory for the affected product.
2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours.
Please share this information with your staff and retain this notification as part of your documentation.
Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425." |
Quantity in Commerce | 75 units |
Distribution | Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DZE
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