Class 2 Device Recall SnapShot" Fixation System

• Date Initiated by Firm: October 25, 2017
• Create Date: March 14, 2018
• Recall Status: Terminated on May 12, 2020
• Recall Number: Z-1009-2018
• Recall Event ID: 79273
• 510(K)Number: K143037
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: fastener, fixation, nondegradable, soft tissue
• Code Information: Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• Manufacturer Reason for Recall: It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
• FDA Determined Cause: Process control
• Action: In October of 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers requesting that any remaining product be quarantined and returned to recalling firm. Questions or concerns can be directed to 574-371-3071.
• Quantity in Commerce: 429 units
• Distribution: TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
• 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