SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access durin
FDA device recall Z-1909-2011 · posted 2011-04-08 · Terminated
Recall details
- Recalling firm
- Transenterix, Inc
- Reason for recall
- Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 305 units
- Distribution
- Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
- Date initiated
- 2011-02-25
- Date posted
- 2011-04-08
- Date terminated
- 2011-11-07
- Location
- Morrisville, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 (K090902) | Transenterix, Inc. | 2009-07-22 |