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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen LPS

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  Class 2 Device Recall NexGen LPS see related information
Date Initiated by Firm July 24, 2017
Create Date February 21, 2018
Recall Status1 Terminated 3 on April 16, 2018
Recall Number Z-0663-2018
Recall Event ID 78960
PMA Number P060037 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
Product NexGen LPS Femoral Component, Left and Right, Size G

Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Code Information Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
Recalling Firm/
Manufacturer		 ZIMMER ORTHOPEDIC MFG LTD
Building No 2 East Park
Shannon Industrial Estate
Shannon Ireland
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
FDA Determined
Cause 2		 Reprocessing Controls
Action On approximately July 24, 2017, customers were notified via letter of the recall. Instructions for distributors included to ensure affected personnel are aware of the recall, locate and quarantine any affected product in inventory, complete and return the Inventory Return Certification Form, make arrangements to return the product Zimmer Biomet, and provide customers if product was further distributed. Instructions for Risk Managers at medical facilities include to ensure affected personnel are aware of the recall, to assist the Zimmer Biomet sales representative in identifying and quarantining affected devices so they can be removed by the sales representative, and to complete and return the Certification of Acknowledgement form. Further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. or 1 (800) 613-6131
Quantity in Commerce 7 devices
Distribution Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
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.
PMA Database PMAs with Product Code = NJL and Original Applicant = ZIMMER, INC.
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