Class 2 Device Recall MTX Dental Implant

• Date Initiated by Firm: November 20, 2017
• Create Date: December 22, 2017
• Recall Status: Terminated 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/ Manufacturer: Zimmer Dental Inc; 1900 Aston Ave; Carlsbad CA 92008-7308
• For Additional Information Contact: Zimmer Dental Customer Service; 561-776-6988
• 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: 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