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U.S. Department of Health and Human Services

Class 2 Device Recall The 2nd Assist Knee Positioner

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  Class 2 Device Recall The 2nd Assist Knee Positioner see related information
Date Initiated by Firm September 07, 2017
Create Date February 28, 2018
Recall Status1 Terminated 3 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/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
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 2
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.