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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
EndoWrist		see related information
Date Posted March 28, 2007
Recall Number Z-0660-2007
Product 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Code Information The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected: 0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
Reason for
Recall		 The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
Action The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.
Quantity in Commerce 8
Distribution Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.
 
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