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Class 2 Device Recall EndoWrist |
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Date Initiated by Firm |
March 24, 2005 |
Date Posted |
March 28, 2007 |
Recall Status1 |
Terminated 3 on November 28, 2007 |
Recall Number |
Z-0660-2007 |
Recall Event ID |
37436 |
510(K)Number |
K012833
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Product Classification |
surgical instrument - Product Code NAY
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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 CA 94086-5206
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Manufacturer Reason for Recall |
The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
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FDA Determined Cause 2 |
Other |
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. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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