Class 2 Device Recall PFC Steinman Pin/Drill Pack Sterile (WPC 6672012)

• Date Initiated by Firm: March 12, 2012
• Date Posted: April 16, 2012
• Recall Status: Terminated on March 06, 2013
• Recall Number: Z-1426-2012
• Recall Event ID: 61342
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit); ; The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces of 1/8 Target Drill Bit product code 513-4193-01 and 4 pieces of Steinman Pin product code 086-9117-00. The Drill Bits are 0.125 in diameter and 5 long. The Steinman Pins in this pack are 0.125 in diameter and 3 long. The pack is provided sterile to the customer and is intended for one time use. The contents of the pack provide stable fixation of the femoral or tibial cutting blocks to the bone while a cut is made.
• Code Information: Product code: 864192 Lot: 167026,167034, 167035
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: Mindy Tinsley; 574-372-7136
• Manufacturer Reason for Recall: Sterility of the pins is at risk because product packaging, which is designed to include 2 pouches (inner pouch and outer pouch) around the pin mounting card only, contains a single pouch, which could compromise product sterility.
• FDA Determined Cause: Packaging process control
• Action: The firm, DePuy Orthopedics Inc., sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" dated March 12, 2012 to its customers via mail or in person with written communication. The notice described the product, problem and actions to be taken. The customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN. The sales representatives are expected to aid customer in returning of recalled products. Distributors and sales representatives are to return the recalled products through the normal DePuy Returns process, to attention of Returns and marking H12-01 on the outside of the box. The customers were also instructed to complete and return the Reconciliation Form to their Depuy Sales Representative or fax to 574-372-7567. Follow-ups for the Reconciliation Form for non-responders will be conducted with the Distributors until the form is returned. For Hospitals that are now out of business or refuse to sign the response card, the Distributor will indicate this on the Reconciliation form and return. For questions about the recall information provided, please contact Manager of Customer Quality, at 574-372-7333 (M-F; 8am - 5pm EST). For product-related questions, please contact your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact Depuy's Scientific Information Office at 1-888-554-2482 (M-F; 8am - 5pm EST).
• Quantity in Commerce: 40 of each lot, 120 total
• Distribution: Nationwide distribution: USA including states of: FL, LA, TX, OR, CA, AZ, KY, GA, MS, and PA.
• 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.