Z-2028-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2012
- Initiation Date
- May 23, 2012
- Termination Date
- March 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108
Product Description
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.
Reason for Recall
The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
Distribution Pattern
USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
Code Information
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.