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U.S. Department of Health and Human Services

Class 2 Device Recall PKG, BIPOLAR FORCEPS, PADDLE

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 Class 2 Device Recall PKG, BIPOLAR FORCEPS, PADDLEsee related information
Date Initiated by FirmNovember 17, 2014
Date PostedDecember 12, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall NumberZ-0693-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
ProductPKG, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351. 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 816247 816248 817088 817415 817476 913562 913563 913828 913829 913830 915433 915678 915679 915680 915792 915891 915892 915893 915949 1013276 1013838 1014368 1014638 1014639 1014750 1014943 1015257 1016064 1016065 1016066 1016067 1016198 1016250 1016735 1016737 1016738 1214971 1215297 1215300 1216025 1216026 1216027 1216028 1216822 1216823 1216824 1217033 1315269 1315270 1315932 1315985 1316201 1316305 1410091 1410847 1410875 1913567 
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
ActionStryker 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 Commerce180,573 units total
DistributionWorldwide 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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