Class 2 Device Recall Smooth or threaded metallic bone fixation fastener

• Date Initiated by Firm: October 11, 2017
• Create Date: March 15, 2018
• Recall Status: Terminated on May 07, 2020
• Recall Number: Z-1071-2018
• Recall Event ID: 79263
• 510(K)Number: K103145
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
• Code Information: 906512, 906513, 906514, 906515
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• Manufacturer Reason for Recall: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
• FDA Determined Cause: Vendor change control
• Action: Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated October 16, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory and quarantine affected product, which will be returned to Biomet through a sales representative. Questions or concerns can be directed to 574-371-3071
• Quantity in Commerce: 14,461
• Distribution: US Nationwide Distribution
• 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 = MBI