Class 2 Device Recall Intuiitve Surgical da Vinci EndoWrist

• Date Initiated by Firm: March 09, 2005
• Date Posted: April 22, 2005
• Recall Status: Terminated on May 13, 2005
• Recall Number: Z-0723-05
• Recall Event ID: 31360
• 510(K)Number: K021036
• Product Classification: Scissors, General, Surgical - Product Code LRW
• Product: Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01
• Code Information: FDA Device Listing Number R100529, Model Number 400178-01. 510(k) number K021036.
• FEI Number: 3001675293
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 950 Kifer Rd; Sunnyvale CA 94086-5206
• For Additional Information Contact: Customer Service; 408-523-2100
• Manufacturer Reason for Recall: Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
• FDA Determined Cause: Other
• Action: The firm has sent notification letters to its consignees on 03/09/2005. Consignees are requested to return the feedback form provided by Intuitive Surgical, via Federal Express.
• Quantity in Commerce: 278 units have been distributed.
• Distribution: The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.
• 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 = LRW