Transenterix Recalls SPIDER Flexible Clip Applier Surgical Instruments
Transenterix is recalling SPIDER Flexible Clip Applier surgical instruments because some units may fail to close clips properly during minimally invasive procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could compromise surgical outcomes, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Transenterix, Inc. is recalling 89 boxes (6 units per box) of SPIDER Surgical Instrument: Flexible Clip Applier. The recall covers units distributed in the United States and in Austria, Germany, Italy, Qatar, and Switzerland. The affected model number is 9000029, with specific lot numbers and expiration dates ranging from March 2013 to May 2014.
The recall was initiated because some clip applier units may be inadequate to achieve clip closure. These 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.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. If the recalled units are found, they should be removed from service and returned to Transenterix, Inc. according to the company's instructions.
The recalled product
- 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…
- Manufacturer
- Transenterix, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- Lot #DC102122
Distribution
Distributed nationwide across the United States.
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