Devices

Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instruments

Model / Serial
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.
Product Classification
Obstetrical and Gynecological Devices
Device Class
2
Implanted device?
No
Distribution
USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
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.
Manufacturer
Integra Limited
1 Event
- Recall of Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instruments

Manufacturer

Integra Limited

Manufacturer Address
Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
Source
USFDA

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