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.
FDA Recall Z-2028-2012 · Posted 2012-07-18
Recalling FirmIntegra Limited
Recall StatusTerminated
Product CodeKNF
Date Initiated2012-05-23
Date Terminated2013-03-19
Product Quantity108
Reason for Recall
The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
Firm Action
Integra sent a Urgent Field Corrective Action letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter instructed customers and sales reps to return the instruments identified on the attached part number list and complete a "Field Corrective Action Acknowledgement and Return Form" to be completed and returned to the firm.
We apologize for any inconvenience this issue may cause you. Please call Integra Surgical Customer Service at 800-431-1123 if you have any questions.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.