Recall Z-1909-2011 ยท GCJ Laparoscope, General & Plastic Surgery
Transenterix, Inc
SPIDER 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.
| Date | Apr 8, 2011 (initiated Feb 25, 2011) |
| Status | Terminated |
| Reason | Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery. |
| Root 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 servic |
| Quantity | 305 units |
| Distribution | Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090902 | SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 Transenterix, Inc., Jul 22, 2009 |