Class 2 Device Recall Moore Hip Prosthesis Long Fenestrated Stem

• Date Initiated by Firm: July 01, 2014
• Date Posted: August 13, 2014
• Recall Status: Terminated on January 09, 2015
• Recall Number: Z-2215-2014
• Recall Event ID: 68654
• Product Classification: Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
• Product: Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length.; ; Product Usage:; The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement.
• Code Information: Part 00402100838, Lot 62435853; Part 00402100841, Lot 62435854; Part 00402100843, Lot 62396506; Part 00402100844, Lot 62424468; Part 00402100848, Lot 62435852; Part 00402100848, Lot 62467218; Part 00402100848, Lot 62511381; Part 00402100851, 37108214; Part 00402100852, Lot 62511377; Part 00402100854, Lot 62511379; Part 00402101241, Lot 62352570; Part 00402101244, Lot 62424469; Part 00402101246, Lot 62400669; Part 00402101248, Lot 62400670; Part 00402101249, Lot 62467222; Part 00402101251, Lot 62470576; Part 00402101252, Lot 62435851; Part 00402101254, Lot 62424470; Part 00402101257, Lot 62524114; & Part 00402101260, Lot 62524115.
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-447-5633
• Manufacturer Reason for Recall: Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lot
• FDA Determined Cause: Packaging process control
• Action: On July 1, 2014 Zimmer, Inc. issued recall notification to their consignees via letter. This notice was issued to affected distributors and hospitals with instructions for returning the affected product. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product and providing related contact information (name, address, and phone number). Distributors are to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative.
• Quantity in Commerce: 68
• Distribution: Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.
• 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.