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U.S. Department of Health and Human Services

Class 2 Device Recall Replant Overdenture Abutment

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  Class 2 Device Recall Replant Overdenture Abutment see related information
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
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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