Class 2 Device Recall PKG, GRASPER FORCEPS, SERRSTED FENESTRATED

• Date Initiated by Firm: November 17, 2014
• Date Posted: December 12, 2014
• Recall Status: Terminated on July 17, 2015
• Recall Number: Z-0681-2015
• Recall Event ID: 69838
• Product Classification: Endoscope and/or accessories - Product Code KOG
• Product: PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318.; Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
• Code Information: 543367 544893 842088 845454 941849 942135 942844 943742 945442 1040419 1041098 1042499 1042929 1043777 1044526 1044527 1045033 1045372 1047071 1141219 1141973 1142134 1142913 1143973 1144935 1145348 1145796 1146957 1147046 1241906 1243270 1244187 1246179 1341468 1341557 1343701 1344283 1344526 1345529 1346236 1346680 1440403 1440910 1442176 1442809 1443395 1443652 646462
• Recalling Firm/ Manufacturer: Stryker Endoscopy; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: 408-754-2000
• Manufacturer Reason for Recall: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
• FDA Determined Cause: Error in labeling
• Action: Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.
• Quantity in Commerce: 180,573 units total
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.