Class 2 Device Recall ConMed Linvatech Hall Surgical Blades, Sterile ST REPL BLADE/STRYKER RECIP

• Date Initiated by Firm: February 21, 2008
• Date Posted: January 15, 2009
• Recall Status: Terminated on January 15, 2009
• Recall Number: Z-0393-2009
• Recall Event ID: 47848
• Product Classification: Surgical Instrument Motors and Accessories/Attachments - Product Code GET
• Product: ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/STRYKER RECIP, Catalog # 00505233400, 00505233200, 00505923500, 00507210100, 00507218100, and 00505331100. ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
• Code Information: BBD26844, BBD31762, BBD29764, BBD31410, BBD32422, BBD33239, BBD23982, BBD23984, BBD24119, BBD27960, BBD29447, BBD29955, BBD30369, BBD34560, BBD22170, BBD22834, BBD23696, BBD26858, BBD28118, BBD29765, BBD38307, BBD27277, BBD22404, BBD24461, and BBD30512.
• Recalling Firm/ Manufacturer: Linvatec Corp.; 11311 Concept Boulevard; Largo FL 33773
• For Additional Information Contact: 727-392-6464
• Manufacturer Reason for Recall: Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
• FDA Determined Cause: Process control
• Action: An Urgent Medical Device Recall letter was issued. Customers must check their facility's inventory immediately for the catalog and lot numbers in the attached list. They also need to complete and sign the enclosed Reply Form and mail or fax the Reply Form to ConMed Linvatec using the enclosed self addressed postage paid envelope or fax 727-319-5701. Customers have an option to either re-sterilize the products using the re-sterilization instructions in the letter or they can return the devices to ConMed Linvatec for a credit using the enclosed preprinted FedEx Air Bill with ConMed Linvatec's Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.
• Quantity in Commerce: 3693
• Distribution: Worldwide Distribution
• 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.