Class 2 Device Recall The 2nd Assist Knee Positioner

• Date Initiated by Firm: September 07, 2017
• Create Date: February 28, 2018
• Recall Status: Terminated on August 23, 2018
• Recall Number: Z-0803-2018
• Recall Event ID: 79141
• Product Classification: Table, surgical with orthopedic accessories, manual - Product Code JEB
• Product: The 2nd Assist Knee Positioner
• Code Information: Item# 740026
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
• FDA Determined Cause: Package design/selection
• Action: On September 12, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to distributors and customers titled "The Second Assistant Disposable Knee Positioner". The notice requests customers to review their inventory and to quarantine any remaining product, which will be returned to the firm. Also, to notify any additional accounts which may have received product from you. Questions or concerns can be directed to Customer Service at 574-371-3071
• Quantity in Commerce: 38,879 units
• Distribution: Nationally
• 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.