FDA Recall Terminated

SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization.

Recall: Z-2137-2012 · Initiated July 2, 2012

Recall

Recall Number: Z-2137-2012
Event Number: 62583
Firm: Transenterix, Inc
FEI Number: 3007593944
Product Code: GCJ
Status: Terminated
Root Cause: Process control
Initiated: July 2, 2012
Posted: August 3, 2012
Terminated: February 27, 2013
Address: 635 Davis Dr, Ste 300, Morrisville, NC, 27560-7183

Description

Reason

Some clip applier units may be inadequate to achieve clip closure.

Action

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 [email protected]. For questions customers were instructed to call 1-888-879-4111. For questions regarding this recall call 919-765-8420.

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland

Quantity

89 boxes(6 units per box)