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U.S. Department of Health and Human Services

Class 2 Device Recall AGC Porous Patellar Med

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  Class 2 Device Recall AGC Porous Patellar Med see related information
Date Initiated by Firm August 25, 2017
Create Date February 15, 2018
Recall Status1 Open3, Classified
Recall Number Z-0628-2018
Recall Event ID 79095
510(K)Number K833921  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.

Product Usage:
For use in Total Knee Arthroplasty.
Code Information Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410).
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-371-3071
Manufacturer Reason
for Recall
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
FDA Determined
Cause 2
Process change control
Action Consignees were notified via mail on approximately 08/25/2017. Instructions to distributors, sales representatives, and distributor operations managers include to ensure affected team members are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide any additional hospitals and/or surgeons that received direct shipments. Instructions to risk managers and surgeons include to ensure affected personnel are informed of the recall, quarantine all affected product, return any affected product in inventory, and complete and return the Certificate of Acknowledgment. Questions or concerns can be sent to the Zimmer Biomet customer call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday. Or they can be sent via email to corporatequality.postmarket@zimmerbiomet.com.
Quantity in Commerce 11 devices
Distribution US Nationwide Distribution to IN, MO, NY, TX.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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