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U.S. Department of Health and Human Services

Class 2 Device Recall PKG, 5MM MULTIFUNCTION PEEK HANDLE,

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  Class 2 Device Recall PKG, 5MM MULTIFUNCTION PEEK HANDLE, 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-0755-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
Product PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106
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 42796 42801 42802 42804 43268 44023 44024 1192011 143481 0200156B 0244656B 0245398C 0246061C 0246312C 0246366C 0246986C 3222012 0341249C 0344478C 04132012E 0441343C 0441354C 0441355C 0444499C 0444505D 0445113C 0542481D 0542486D 0542488D 0542514D 06272013E 0641983D 0641985D 0641990D 0641991D 0641993D 0641996D 0641998D 0641999D 0642003D 0647975D 06CON02508 06CON05664 06CON06127 06CON08812 07232013E 7282014 0742752D 0742755D 0744892D 0744893D 0744894D 0744895D 0744899D 0744902D 0744905D 0744907D 0744908D 0744910D 0744911D 08012013E 08022013E 0812011E 8122010 08152013E 08292013E 0841786D 0842288D 8422890 0842290D 0842292D 0842294D 0842298D 09192013E 0940016D 0940020D 0940023D 0940026D 0940029D 0940032D 0940038D 0940043D 0940049D 0940053D 0940059D 0940066D 0940072D 0940076D 0940081D 0940089D 0940094D 0940097D 0940103D 0940109D 0940115D 0944842D 0944843D 0944848D 0944850D 0944853D 0944857D 0944858D 0944861D 0944864D 0944867D 0944869D 0944872D 0944876D 0944880D 0944881D 0944884D 0944890D 0944895D 0944899D 0944901D 0944904D 0944907D 0944908D 0944913D 0944917D 0944923D 1042517D 1042519D 1044896D 1044897D 1044899D 1045191D 1045202D 1045204D 1045385D 1045387 1045387D 1045389D 1045936D 1045939D 1045941D 1045943D 1046169D 1046737D 1046738D 1046741D 1046742D 11172011E 1140697D 1140698D 1140699D 1141724D 1141725D 1141728D 1141730D 1142227D 1142228D 1142411D 1142412D 1143086D 1143087D 1143440D 1143441D 1144680D 1144681D 1144683D 1144685D 1144686D 1144688D 1144690D 1144897D 1144898D 1144899D 1145468D 1145469D 1145470D 1145472D 1146373D 1146374D 1146375D 1146389D 1146391D 1146393 1146393D 1146395D 1146396D 1146398D 1146711D 1146712D 1146713D 1146716D 1146718D 1146843D 1240626D 1240627D 1240963D 1240964 1240964D 1240965 1240966 1240967 1240967D 1240968 1240969 1240970 1242396 1243805 1243805D 1243806 1244703 1244703D 1244704 1245037 1245038 1245039 1245040 1245041 1245095 1245097 1245098 1245100 1245103 1245860 1245860D 1245861 1245862 1246032 1341115 1341115H 1341243 1341244 1341244H 1341245 1341245H 1341448 1341448H 1341449 1341874 1341874H 1342206 1342207 1342207H 1342208 1342209 1342209H 1342854 1342854H 1342855 1342856 1342857 1342857H 1343536 1343536H 1343537 1343537H 1343538 1343539 134538H 1440291 1441859 1442305 1442556 1442557 1442558 144690D 742754D 343866 0540414D 0647976D 0840342D 0940047D 0940172D 0941829D 0942246D 0942854D 0943250D 0943418D 0945753D 1040547D 1040624D 1040988D 1041612D 1042958D 1043506D 1044529D 1045021D 1045374D 1045375D 1046177D 1046935D 1046939D 1141412 1141412D 1141413D 1141414D 1142929D 1143151D 1144226D 1144304D 1144649D 1144650D 1145685D 1145686D 1240105D 1240106D 1241868D 1243264 1245441 1246153 1341013 1341602 1341603 1343723 1343723H 1344272 1346099 1440415 1440416 
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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