Class 2 Device Recall MicroChoice

• Date Initiated by Firm: January 24, 2003
• Date Posted: April 10, 2003
• Recall Status: Terminated on July 07, 2012
• Recall Number: Z-0717-03
• Recall Event ID: 25709
• 510(K)Number: K942660
• Product Classification: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment - Product Code HWE
• Product: Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
• Code Information: Units under recall include the following serial numbers: 3582 thru 3681, 3685 thru 3733, 3739 thru 3766, 3768, 3800 thru 3809 (74 units)
• FEI Number: 1017294
• Recalling Firm/ Manufacturer: Linvatec Corp DBA Linvatec/Hal; 11311 Concept Blvd.; Largo FL 33773
• For Additional Information Contact: Fred Trimble; 727-392-6464
• Manufacturer Reason for Recall: The Footswitch functions of the left and right foot pedals may be reversed in some units.
• FDA Determined Cause: Other
• Action: The firm telephoned and mailed a Recall Notification letter with response form to all Accounts beginning on 1/24/03. Distributors were asked to subrecall down to the medical facility level. Recalled devices are to be returned to Linvatec for testing.
• Quantity in Commerce: 74
• Distribution: Nationwide, worldwide.
• 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.

• 510(K) Database: 510(K)s with Product Code = HWE