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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Dental Tapered ScrewVent T Implant

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  Class 2 Device Recall Zimmer Dental Tapered ScrewVent T Implant see related information
Date Initiated by Firm June 25, 2014
Date Posted July 14, 2014
Recall Status1 Terminated 3 on October 30, 2014
Recall Number Z-2050-2014
Recall Event ID 68584
510(K)Number K101977  K101880  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Code Information Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
FDA Determined
Cause 2		 Under Investigation by firm
Action Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information.
Quantity in Commerce 129 units
Distribution Nationwide Distribution.
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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