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U.S. Department of Health and Human Services

Class 2 Device Recall Persona PS Conventional Articular Surfaces 18MM L 1011 EF

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  Class 2 Device Recall Persona PS Conventional Articular Surfaces 18MM L 1011 EF see related information
Date Initiated by Firm March 17, 2016
Date Posted April 06, 2016
Recall Status1 Terminated 3 on March 14, 2017
Recall Number Z-1341-2016
Recall Event ID 73498
510(K)Number K113369  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18
Code Information lot 62632101
Recalling Firm/
Manufacturer
Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall
The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
FDA Determined
Cause 2
Employee error
Action Distributors, Sales Representatives, Operation Managers, and Hospital Risk Managers will be provided with an "Urgent Medical Device Recall-Lot Specific" letter.
Quantity in Commerce TBD
Distribution Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
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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