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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch

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  Class 2 Device Recall ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch see related information
Date Initiated by Firm August 30, 2005
Date Posted August 29, 2006
Recall Status1 Terminated 3 on July 13, 2012
Recall Number Z-1444-06
Recall Event ID 33326
Product Classification footswitch - Product Code GEY
Product ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces.
Code Information Serial numbers BBB81339-BBB81407, BBB91192-BBB91194, BBBB91209-BBB91366 and BBB91664-BBB91672.
Recalling Firm/
Manufacturer		 Linvatec Corp.
11311 Concept Blvd
Largo FL 33773-4908
Manufacturer Reason
for Recall		 The footswitch may develop a system fault resulting in the self-activation of the handpiece it controls, or it may cause the handpiece to run intermittently or to revert to a default setting.
FDA Determined
Cause 2		 Other
Action Linvatec has issued recall notification to all it''s direct accounts. The mailings were sent by UPS 08/31/2005. Each consignee was requested to return the affected product to Linvatec for a free replacement footswitch.
Quantity in Commerce 118
Distribution Worldwide, including United States 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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