Class 2 Device Recall PKG, 5MM PEEK HANDLE, 45CM

• Date Initiated by Firm: November 17, 2014
• Date Posted: December 12, 2014
• Recall Status: Terminated on July 17, 2015
• Recall Number: Z-0757-2015
• Recall Event ID: 69838
• Product Classification: Endoscope and/or accessories - Product Code KOG
• Product: PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164; 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: 01292013D 0247065C 0341845C 0342941C 0345124C 0345125C 4082014 0540391C 0540392CD 0542893D 0647218D 07122013E 0743480D 0744062D 0843047D 0845027D 0845859D 0846783D 0940144D 0940148D 0940821D 0941601D 0943110D 0943251D 0943541D 0944721D 0945231D 0945465D 1040630D 1040806D 1041063D 1041468D 1042102D 1043037D 1043039D 1044650D 1045037D 1045055D 1045227D 1045481D 1045638D 1045841D 1046702D 11082010A 1141562 1141562D 1141969D 1141970D 1142168D 1143113D 1143150D 1144236D 1144341D 1144655D 1145341D 1145632D 1145809D 1145939 1145939D 1146669D 1146671D 12122013 1241797D 1241938D 1243268D 1243269D 1244956 1244956D 1245522 1245798 1245799 1245799H 1245800 1245977 1340938 1341257 1341872 1343540 1343540H 1343541 1343542 1344000 1344000H 1344251 1440346 1440346H 1440347 1440347H 1440792 1442304 1442799
• 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.