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U.S. Department of Health and Human Services

Class 2 Device Recall TaperedScrew Vent Implant

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  Class 2 Device Recall TaperedScrew Vent Implant see related information
Date Initiated by Firm July 17, 2014
Date Posted August 02, 2014
Recall Status1 Terminated 3 on February 06, 2015
Recall Number Z-2144-2014
Recall Event ID 68862
510(K)Number K011028  K013227  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Code Information Lot No. 62552804
Recalling Firm/
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
Manufacturer Reason
for Recall
Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."
FDA Determined
Cause 2
Process design
Action A recall letter dated 7/22/14 was sent to all customers who purchased the Tapered Screw-Vent Implant to inform them of the recall by Zimmer Dental. The letter informs the customers of the problems identified, risks involved, and the actions to be taken. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, 7-5pm, Mon-Fri. Customers are instructed to complete the customer response form and e-mail a copy to corporatequality.postmarket@zimmer.com or fax to (574) 372-4265.
Quantity in Commerce 291 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.
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 = SULZER DENTAL, INC.