Recall Z-2137-2012— Transenterix, Inc
Class II · Terminated
Class II FDA medical device recall by Transenterix, Inc, initiated 2012-07-02, terminated 2013-02-27. It names one FDA 510(k) clearance: K091697. 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.. Reason: Some clip applier units may be inadequate to achieve clip closure..
- Recalling firm
- Transenterix, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-02
- Terminated
- 2013-02-27
- Firm location
- Morrisville, NC, United States
510(k) clearances named in this recall
1 on FDA's record- K091697 — SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Some clip applier units may be inadequate to achieve clip closure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.