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.
Recall
- Recall Number
- Z-1910-2011
- Event Number
- 58093
- Firm
- Transenterix, Inc
- FEI Number
- 3007593944
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 25, 2011
- Posted
- April 8, 2011
- Terminated
- November 7, 2011
- Address
- 635 Davis Dr, Ste 300, Morrisville, NC, 27560-7183
Description
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.
Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
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.
Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
92 units