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U.S. Department of Health and Human Services

Class 2 Device Recall PFC Sigma Round Dome Patella

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  Class 2 Device Recall PFC Sigma Round Dome Patella see related information
Date Initiated by Firm June 28, 2011
Date Posted August 30, 2011
Recall Status1 Terminated 3 on August 28, 2013
Recall Number Z-3099-2011
Recall Event ID 59238
510(K)Number k884796  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product PFC Sigma Round Dome Patella 38 MM 3 Peg

Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement.
Code Information Product code 960112, Lot number 3292209
Recalling Firm/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Depuy Orthopaedics
Manufacturer Reason
for Recall
DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the packaging is labeled for a P.F.C. SIGMA 38mm 3 peg Round Dome Patella, but the product enclosed in the package is a P.F.C. SIGMA 35mm 3 peg Oval Dome Patella.
FDA Determined
Cause 2
Employee error
Action The firm, Depuy , sent an email that included a letter entitled "URGENT INFORMATION - RECALL NOTICE" dated June 28, 2011 to DePuy Area customers ( Directors, Distributors, Office Managers, Hospital Representatives, and Doctors). The letter described the product, problem and actions to be taken. The letter also included implications of implanting the recalled device and patient communication information. The customers were instructed to immediately cease further implantation/use or distribution of the product, immediately return any recalled devices in their inventory, notify their customer of the recall and complete, sign and return the Reconciliation Form(s) via fax to DePuy at 574-372-7567 within seven business days. The letter also states that DePuy is not recommending prophylactic revision or additional follow up in the absence of symptoms. Additionally, DePuy recommends that surgeons continue to follow patients as per their standard care. Questions regarding the recall may be directed to the following DePuy representatives--questions about recall information call the Manager of Customer Quality at 574-372-7333; Salesforce questions, call the Group Product Director, 574-372-5046 or Associate Product Director at 574-372-7154 and for Clinical/Surgeon questions, contact DePuy's Scientific Information Office at 1-888-554-2482.
Quantity in Commerce 29
Distribution Nationwide distribution: CA, MI, NJ and WI.
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 = JOHNSON & JOHNSON PROFESSIONALS, INC.