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U.S. Department of Health and Human Services

Class 2 Device Recall Tapered ScrewVent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform

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  Class 2 Device Recall Tapered ScrewVent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform see related information
Date Initiated by Firm January 06, 2014
Date Posted January 28, 2014
Recall Status1 Terminated 3 on July 07, 2014
Recall Number Z-0847-2014
Recall Event ID 67207
510(K)Number K072589  
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008.

Class II, 510(k) K13227.
Code Information Catalog Number TSVWB11, Lot 62470008.
Recalling Firm/
Manufacturer
Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information Contact
760-929-4107
Manufacturer Reason
for Recall
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state ¿3.7 x 10mm instead of ¿4.7 x 11.5mm.
FDA Determined
Cause 2
Labeling Change Control
Action Zimmer Dental initiated the recall on 01/06/2013 by sending out recall notifications via FedEx to domestic customers and via electric mail to international customers. Customers are sent a letter identifying the issue, product description with codes, risk, instructions, and contact information. The letter's instructions include locating the affected product and return unused product to Zimmer Dental and notifying the amount of product that has been consumed.
Quantity in Commerce 307
Distribution Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
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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