FDAFDA · Food and drugs·Recall number Z-0720-2015
PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 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.
Published December 24, 2014 · Recall initiated: November 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Endoscopy
- Distributor
- 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.
- Lot
- 41466 41467 41729 41883 41892 42212 42256 42312 42811 43249 44279 70809 71009 71309 72209 80409 804092 90809 1008091 1008092 1008093 1008094 1008095 100909 1112011 01112011A 01112011D 141531 141532 142480 142481 142482 143197 143208 0200178B 0200199C 0200200C 02022012E 2132014 02202013E 0244651B 0244851C 0244852C 0244853C 0245331C 0245528C 0245530C 0245531C 0245836C 0245837C 0245838C 0246753C 0246957C 0246958C 0246960C 0247433C 3012011 0341069C 0341543C 0341544C 0341916C 0341917C 0341919C 3419210 0344507C 0344509C 0344513C 0344515C 0344516C 0344519C 0344522C 0344523C 0344526C 0344527C 4012014 040313D 04122011E 04122011T 0443870C 0443871C 0443873C 0443874C 0443875C 0443876C 0443878C 0443879C 0443884D 0443886D 0443887D 0443888D 0443889D 0443890D 0443891D 0443893D 0445107C 5062010 51120102 05162013D 0542119D 0542336D 0542337D 0542338D 0542440D 0542447D 0542449D 0542450D 0542556D 0542558D 0542561D 0542563D 0542564D 0542565D 0543337D 06122013D 6152011 6242010 06272012D 06272013D 0641938D 0641939D 0641942D 0641943D 0641944D 0641947D 0641948D 0641949D 0641950D 0641952D 0641955D 0641956D 0641957D 0641962D 0646241D 0646244D 0646246D 0646249D 0646252D 0646255D 0646258D 0646259D 0646260D 0646262D 0646264D 0646265D 0646266D 0646267D 0646268D 0646270D 0646271D 0646272D 0646273D 0646274D 0646275D 0647210D 06CON05659 06CON05767 06CON05768 06CON06068 06CON06069 06CON06070 06CON06124 06CON08797 06CON08798 7082011 7092014 7102014 07122013D 71309 713092 713093 71409 714091 714092 07232013D 0746365D 0746690D 0746692D 0746693D 0746695D 0746696D 0746698D 0746699D 0746732D 0746734D 0746736D 0746738D 08012013D 08022013D 8082013 08152013D 08292013D 0842561D 842811 0843219D 0843221D 0843225D 0843226D 0843227D 0843235D 0843236D 0843239D 0843240D 0843241D 0843243D 0843245D 0843251D 0843255D 0843257D 0843259D 0843261D 0843263D 0843266D 0843268D 0843704D 0847900D 0847906D 0847908D 0847911D 0847912D 0847915D 0847917D 0847921D 0847925D 0847928D 0847931D 0847933D 0847937D 0847939D 0847943D 0847945D 0847947D 0847952D 0847956D 0847959D 0847964D 0847966D 0847972D 0847976D 9012010 09092013D 9102014 09122012E 09192013D 9222010 9242013 92509 9292010 0940779D 0943248D 0943249D 0943269D 0943270D 0943271D 0943272D 0943274D 0943275D 0943277D 0943280D 0943282D 0943283D 0943285D 0943287D 0943290D 0943291D 0943293D 0943296D 0943298D 0943299D 0943302D 0943305D 0943309D 0943310D 0943314D 0943317D 0943320D 0943321D 0943326D 0944829D 10042013 10102013 1022013D 1040634D 1040637D 1040638D 1040641D 1040647D 1040651D 1040653D 1040655D 1040660D 1040666D 1040667D 1040671D 1040675D 1040680D 1040684D 1040687D 1040689D 1040691D 1040696D 1040700D 1040701D 1040706D 1040712D 1040715D 1040717D 1040719D 1040723D 1044587D 1044590D 1044591D 1044595D 1044597D 1044600D 1044602D 1044604D 1044605D 1044658D 1044661D 1044666D 1044889D 1044890D 1044891D 1044893D 1045360D 1045363D 1045947D 1045967D 1045970D 1045972D 1045974D 1046201D 1046205D 1046208D 1046209D 1046212D 1046215D 1046639D 1046765D 1046767D 1046895D 1046897D 1046899D 1047028D 1047030D 1047033D 1047036D 11142013 11172011 1140694D 1140695D 1140696D 1141146D 1141147D 1141219H 1141569D 1141570D 1141571D 1141572D 1141573D 1141574D 1141576D 1141578D 1141580D 1141582D 1141584D 1141587D 1141732D 1141735D 1141737D 1142229D 1142230D 1142231D 1142232D 1142234D 1142414D 1142415D 1142416D 1142636 1143082D 1143083D 1143084D 1143085D 1143704D 1143705D 1143706D 1143707D 1143708D 1143709D 1143711D 1143712D 1143714D 1144705D 1144706D 1144707D 1144708D 1144709D 1144711D 1145356D 1145357D 1145358D 1145359 1145359D 1145360D 1145361D 1145363D 1145365D 114583
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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