• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

  • Print
  • Share
  • E-mail
-

Product Detail

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.
Recall Number Z-2028-2012
Classification Class II
Code Info 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 Distributed Qty 108
Reason For Recall The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.

Event Detail

Event Id 62464
Product Type Devices
Status Ongoing
Recalling Firm Integra Limited
City Plainsboro
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
-
-