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U.S. Department of Health and Human Services

Class 2 Device Recall MTX Dental Implant

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  Class 2 Device Recall MTX Dental Implant see related information
Date Initiated by Firm November 29, 2017
Date Posted March 05, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-1190-2018
Recall Event ID 78667
510(K)Number K072589  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Code Information Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information Contact
561-776-6988
Manufacturer Reason
for Recall		 Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
FDA Determined
Cause 2		 Packaging process control
Action On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.
Quantity in Commerce 995 distribution events total
Distribution Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
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 = ZIMMER DENTAL INC.
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