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U.S. Department of Health and Human Services

Class 2 Device Recall PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION

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  Class 2 Device Recall PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION see related information
Date Initiated by Firm November 17, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall Number Z-0673-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
Product PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311.
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 44035 140782 244776 245545 343856 441524 442997 540455 544016 544024 646306 646310 646312 646314 646317 646318 747599 747602 747604 747605 747608 840082 8460129 846018 846019 846023 846024 846025 846029 846030 846031 846032 846034 846035 940559 940560 940561 940562 940563 940564 940565 940566 940567 940568 940570 940571 940572 940573 1042186 1042190 1042191 1042192 1042193 1042194 1042195 1042196 1042197 1042198 1042199 1042200 1042201 1043521 1043522 1043523 1046150 1142193 1142194 1144246 1144247 1144936 1144997 1145107 1145223 1146160 1146699 1146700 1146701 1146840 1241180 1241402 1241403 1242704 1242705 1242837 1243090 1243158 1243587 1244005 1244006 1245513 1246061 1246188 1246189 1246190 1340491 1340492 1340712 1340713 1341440 1341837 1341838 1341839 1342205 1342847 1343136 1344422 1345089 1346207 1440342 1440343 1440344 1441218 1441464 641979 
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 2		 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.
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