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.
FDA Recall Z-2137-2012 · Posted 2012-08-03
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Recalling FirmTransenterix, Inc
Recall StatusTerminated
Product CodeGCJ
Date Initiated2012-07-02
Date Terminated2013-02-27
Product Quantity89 boxes(6 units per box)
Reason for Recall
Some clip applier units may be inadequate to achieve clip closure.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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