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U.S. Department of Health and Human Services

Class 2 Device Recall MicroChoice

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  Class 2 Device Recall MicroChoice see related information
Date Initiated by Firm January 24, 2003
Date Posted April 10, 2003
Recall Status1 Terminated 3 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)
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 2		 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 and Original Applicant = HALL SURGICAL, DIVISION OF ZIMMER, INC.
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