Date Initiated by Firm | November 28, 2016 |
Date Posted | January 09, 2017 |
Recall Status1 |
Terminated 3 on February 16, 2017 |
Recall Number | Z-0961-2017 |
Recall Event ID |
75838 |
510(K)Number | K090234 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
|
Product | GoDirect Screw-Retaining Top
Part Numbers: 4500-61 |
Code Information |
Lot #75808 |
Recalling Firm/ Manufacturer |
Implant Direct Sybron Manufacturing, LLC 3050 E Hillcrest Dr Westlake Village CA 91362-3171
|
For Additional Information Contact | Stephanie Bergeron 818-444-3300 Ext. 3323 |
Manufacturer Reason for Recall | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | On 11/28/16 customers were called and instructed to return the product. |
Quantity in Commerce | 14 |
Distribution | U.S. distribution to the following; WA.
Foreign distribution to the following; Netherlands. |
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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