SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in minimally inva
FDA device recall Z-2137-2012 · posted 2012-08-03 · Terminated
Recall details
- Recalling firm
- Transenterix, Inc
- Reason for recall
- Some clip applier units may be inadequate to achieve clip closure.
- Action taken
- TransEnterix sent an Urgent Device Recall letter date July 2, 2012, 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 affected product, remove the affected product from their inventory and either return it or dispose of it to prevent usage. Customers were instructed to complete the attached Inventory Reconciliation Formand return the form even if they no longer have any affected units in their inventory. Customers were instructed to ship the affected product to TransEnterix using the enclosed shipping label. If returning a form only, they should e-mail to adunn@transenterix.com. For questions customers were instructed to call 1-888-879-4111. For questions regarding this recall call 919-765-8420.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 89 boxes(6 units per box)
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland
- Date initiated
- 2012-07-02
- Date posted
- 2012-08-03
- Date terminated
- 2013-02-27
- 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 SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 (K091697) | Transenterix, Inc. | 2009-09-28 |