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U.S. Department of Health and Human Services

Class 2 Device Recall PERSONA" The Personalized Knee System

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  Class 2 Device Recall PERSONA" The Personalized Knee System see related information
Date Initiated by Firm October 07, 2014
Date Posted October 23, 2014
Recall Status1 Terminated 3 on September 23, 2015
Recall Number Z-0123-2015
Recall Event ID 69354
510(K)Number K113369  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for
use in multiple total knee arthroplasty procedures. Per the Persona Surgical
technique, the Persona Tibial Articular Inserter is used to seat the articular surface
implant onto the tibial baseplate.
Code Information Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154.
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		 Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
FDA Determined
Cause 2		 Process control
Action Zimmer sent an " URGENT MEDICAL DEVICE RECALL - LOT SPECIFIC " notifications dated September 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Quantity in Commerce 618 units
Distribution Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
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 = JWH and Original Applicant = ZIMMER INC.
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