Recall Z-2028-2012 ยท KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Integra Limited
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.
| Date | Jul 18, 2012 (initiated May 23, 2012) |
| Status | Terminated |
| Reason | The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 108 |
| Distribution | USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS Integra LifeSciences Corporation, Feb 8, 2012 |