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Recall Observatory FDA recall evidence

Device product

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.

Z-2137-2012

July 02, 2012

Class II

Product summary

Firm
Transenterix, Inc
Event
Event 62583
Status
Terminated
Classification
Class II
Quantity
89 boxes(6 units per box)
Official record key
device-enforcement:Z-2137-2012

Official wording

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

Code information: Model Number: 9000029, Lot #DC301112, Exp. Date: Oct 2013; Lot #DC313111, Exp. Date: Nov 2013; Lot #DC061121, Exp. Date: Mar 2013; Lot #DC082122, Exp. Date: Feb 2014; Lot #DC168112, Exp. Date: Jun 2013; Lot #DC265111 Exp. Date: Sept 2013; Lot #DC341111, Exp. Date: Dec 2013; Lot #DC019125, Exp. Date: Jan 2014; Lot #DC061122, Exp. Date: Mar 2014; Lot #DC082121, Exp. Date: Feb 2014; Lot #DC102122, Exp. Date: Apr 2014; Lot #DC102123, Exp. Date: Apr 2014 and Lot #DC144121, Exp. Date: May 2014.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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