FDAFDA · Food and drugs·Recall number Z-2028-2012
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
Published July 25, 2012 · Recall initiated: May 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra Limited
- Distributor
- USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
- Lot
- Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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