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U.S. Department of Health and Human Services

Class 2 Device Recall MTX Dental Implant

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  Class 2 Device Recall MTX Dental Implant see related information
Date Initiated by Firm November 20, 2017
Create Date December 22, 2017
Recall Status1 Terminated 3 on February 28, 2024
Recall Number Z-0284-2018
Recall Event ID 78635
510(K)Number K101977  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Tapered Screw-Vent MTX Model TSVTB11
Code Information lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794
Recalling Firm/
Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information Contact Zimmer Dental Customer Service
Manufacturer Reason
for Recall
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
FDA Determined
Cause 2
Under Investigation by firm
Action Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected product.
Quantity in Commerce 500 units
Distribution US, Canada, France, Italy, Spain, Germany
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.