Class 2 Device Recall Biomet Microfixation TraumaOne System Surgical Tray

• Date Initiated by Firm: April 11, 2017
• Create Date: May 12, 2017
• Recall Status: Terminated on August 06, 2019
• Recall Number: Z-2073-2017
• Recall Event ID: 77022
• Product Classification: Template - Product Code HWT
• Product: Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
• Code Information: Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720
• Recalling Firm/ Manufacturer: Biomet Microfixation, LLC; 1520 Tradeport Dr; Jacksonville FL 32218-2480
• For Additional Information Contact: Customer Service; 800-348-2759
• Manufacturer Reason for Recall: Part of the number on the tray lid differ from the part number on the base.
• FDA Determined Cause: Under Investigation by firm
• Action: On April 11, 2017 the firm sent notifications to all affected US and International distributors, which will include instructions for returning affected products. All distributors will be notified via electronic mail, and US distributors with product, will be notified via courier. o Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals which currently have the product. o Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the additional accounts form provided in the letter. o Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Attachment 1 form. - Complete and return Attachment 1 (Acknowledgement of Responsibility) to the fax number or email address provided. For more information contact corporatequality.postmarket@zimmerbiomet.com or 904-367-7133 (8:am - 5pm EST)
• Quantity in Commerce: 33 units
• Distribution: AL, MO and UT Canada, Australia, Netherlands, and Egypt
• 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.