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Class 2 Device Recall Zimmer Dental Tapered ScrewVent T Implant |
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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
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Product Classification |
Implant, endosseous, root-form - Product Code DZE
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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
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For Additional Information Contact |
800-613-6131
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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.
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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
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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 and Original Applicant = ZIMMER DENTAL INC.
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