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U.S. Department of Health and Human Services

Class 2 Device Recall Persona EM Distal Rod

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  Class 2 Device Recall Persona EM Distal Rod see related information
Date Initiated by Firm November 24, 2015
Date Posted December 10, 2015
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0411-2016
Recall Event ID 72714
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
Code Information Distal Rod Item Number 42-5399-002-00 Lots: 62137112, 62156914, 62222599.
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin W. Escapule
574-372-4487
Manufacturer Reason
for Recall		 Complaints that the ratchet teeth of the tube are not latching onto the rod.
FDA Determined
Cause 2		 Under Investigation by firm
Action Zimmer Biomet initiated a voluntary recall of the Persona¿ EM Proximal Tube and Persona¿ EM Distal Rod due to complaints that the ratchet teeth of the tube are not latching onto the rod via certified mail on 11/24/2015. The firm requests customers quarantine recalled devices, return the customer response forms, and assist in returning the devices to the Zimmer Biomet sales reps. Customers with questions may contact 1-800-348-2759 between 8:00 am and 8:00 pm EST.
Quantity in Commerce 156
Distribution Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.
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.
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