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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Linvatec

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  Class 2 Device Recall ConMed Linvatec see related information
Date Initiated by Firm December 20, 2005
Date Posted November 16, 2006
Recall Status1 Terminated 3 on July 11, 2012
Recall Number Z-0179-2007
Recall Event ID 34438
Product Classification Sternum Saw Collet Nut - Product Code KFK
Product ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually.
Code Information All serial numbers are being recalled.
Recalling Firm/
Manufacturer		 Linvatec Corp.
11311 Concept Blvd
Largo FL 33773-4908
Manufacturer Reason
for Recall		 The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations.
FDA Determined
Cause 2		 Other
Action Linvatec will send each consignee a recall package that will include: a 12/20/2005 recall letter and reply form, A product correction instruction sheet , a new Sternum Saw Collet Nut and an assembly manual. Linvatec will also contact each consignee by phone or email. All consignees that have not responded by 30 days after the first mailing will be re-contacted by the firm by mail, phone or email.
Quantity in Commerce 11424 units
Distribution Worldwide, including USA, Mexico, and 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.
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