Class 2 Device Recall SPIDER ADVANCED Surgical Platform

• Date Initiated by Firm: February 25, 2011
• Date Posted: April 08, 2011
• Recall Status: Terminated on November 07, 2011
• Recall Number: Z-1910-2011
• Recall Event ID: 58093
• 510(K)Number: K102839
• Product Classification: Laparoscope, general &, plastic surgery - Product Code GCJ
• Product: SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.
• Code Information: Model number: 9000021, Lot numbers: TRX056201001, TRX061201002, TRX071201001, TRX086201003.
• Recalling Firm/ Manufacturer: Transenterix, Inc; 635 Davis Dr Ste 300; Morrisville NC 27560-7183
• For Additional Information Contact: Tammy B. Carrea; 919-765-8420
• Manufacturer Reason for Recall: Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
• FDA Determined Cause: Other
• Action: TransEnterix sent an Urgent Device Recall letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the lot numbers affected, complete the attached inventory reconciliation form and return the form, along with any affected product to TransEnterix using the enclosed shipping label. Customers were asked to return the inventory form even if they had none of the lot numbers affected in their inventory. Their sales representative and customer service will work with them to replace the product in full at not cost to them. For questions regarding this recall contact TransEnterix Customer Care at 1-888-879-4111.
• Quantity in Commerce: 92 units
• Distribution: Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
• 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 = GCJ