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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Linvatech Hall Surgical Blades, Sterile OSC BLADE

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  Class 2 Device Recall ConMed Linvatech Hall Surgical Blades, Sterile OSC BLADE see related information
Date Initiated by Firm February 21, 2008
Date Posted January 15, 2009
Recall Status1 Terminated 3 on January 15, 2009
Recall Number Z-0366-2009
Recall Event ID 47848
Product Classification Surgical Instrument Motors and Accessories/Attachments - Product Code GET
Product ConMed Linvatec Hall Surgical Blades, Sterile OSC BLADE, Catalog # 00507116100 and 00507158200.

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 BBD43667, BBD21975, BBD23363, BBD24458, BBD24638, BBD26620, BBD26627, BBD27075, BBD27077, BBD27090, BBD32433, BBD33296, BBD34463, BBD34549, BBD34807, BBD35209, BBD40829, BBD41004, BBD24642, BBD28015, BBD29443, BBD31411, BBD32429, BBD33298, BBD34804, BBD35917, BBD38050, BBD39010, BBD41001.
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 2		 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 7531
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.
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