Reported Aug 15, 2012 · Terminated
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally…
Transenterix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Transenterix, Inc · 635 Davis Dr Ste 300 · Morrisville, NC · 27560-7183
Is this the product you have?
- SPIDER Surgical InstrumentFlexible 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
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Product as published 9000029Lot #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. - Amount recalled
- 89 boxes(6 units per box)
Where it was sold
- Nationwide
Why it was recalled
Some clip applier units may be inadequate to achieve clip closure.
This product could cause temporary or reversible health problems — stop using it.
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