Class 2 Device Recall PFC Sigma Round Dome Patella

• Date Initiated by Firm: June 28, 2011
• Date Posted: August 30, 2011
• Recall Status: Terminated 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
• FEI Number: 1818910
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: Depuy Orthopaedics ; 800-366-8143
• 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: 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