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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal Zimmer Dental implant

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  Class 2 Device Recall Trabecular Metal Zimmer Dental implant see related information
Date Initiated by Firm January 06, 2016
Date Posted February 09, 2016
Recall Status1 Terminated 3 on May 06, 2016
Recall Number Z-0779-2016
Recall Event ID 73013
510(K)Number K112160  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product IMPLANT,TM, MTX FULL
4.1 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMT4B11

Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Code Information Lot # 63192990 63203112 63236810
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information Contact Zimmer Dental Customer Service
800-854-7019
Manufacturer Reason
for Recall		 Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
FDA Determined
Cause 2		 Labeling Change Control
Action Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form. It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records. For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
Quantity in Commerce 1059
Distribution Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
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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