• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT 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-0624-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
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 42178 42259 42260 42263 42267 42325 42326 42791 70109 713091 72309 90809 1192010 140575 140800 140807 140864 141289 141292 141401 0200154B 0200176B 0200177B 0245386C 0246314C 0246934C 0246939C 0246940C 0246942C 0247044C 0247047C 0247049C 0340029C 0340679C 0340680C 0340681C 0340682C 0340683C 0341237C 0341241C 0341908C 0341912C 4122011 04242012E 04282011E 0441389C 0441455C 0441456C 441457 0441461C 0441464C 0441465C 0441466C 0441467C 0441468C 0441471C 0441472C 0443282C 0443519C 5022011 5112010 5212010 52120101 52120102 52120103 52120104 05232013D 5252010 0540672D 0540867D 0540868D 0540869D 0540871D 0540872D 0540873D 0540874D 0540877D 0540878D 0540880D 0540881D 0540884D 06040590D 06122012E 6162014 6172011 6272012 06272012E 0640590D 0640591D 0640595D 0640596D 0640606D 0640607D 0640608D 640609 0640610D 0640611D 0640612D 0640613D 0640614D 0640615D 0647215D 06CON06064 06CON06123 06CON06666 7022012 7232014 0741767D 0741768D 0741770D 0741772D 0741773D 0741774D 0741776D 0741777D 0741778D 0745271D 0745276D 0745277D 0745278D 0745279D 0745280D 0745281D 0745282D 0840677D 0840768D 0841627D 0841630D 0841636D 0841640D 0841644D 0841648D 0841648E 0841652D 0841690D 0841699D 0841709D 0841720D 0842601D 0846857D 0846858D 0846860D 0846863D 0846866D 0846873D 0846878D 0846883D 0846887D 0846893D 0846900D 0846904D 0846910D 0846919D 0846923D 0846928D 0846935D 0846944D 0846948D 90209 9072010 9232013 9252012 0944346D 0944349D 0944350D 0944355D 0944360D 0944361D 0944365D 0944368D 0944369D 0944370D 0944375D 0944377D 0944380D 0944382D 0944387D 0944391D 0944393D 0944398D 0944402D 0944404D 0944409D 0944790D 0944795D 0944796D 0946948D 1042510D 1044586D 1045207D 1045209D 10456684D 1045680D 1045681D 1045684D 1046169D 1046170D 1046859D 1046861D 1046863D 1046864D 1046868D 1046869D 1046875D 111299 1141741D 1141742D 1142182D 1142183D 1142184D 1143443D 1143444D 1143445D 1145111D 1145112D 1145474D 1145475D 1145637D 1146568D 1146569D 1146570D 1146571D 1240176D 1240177D 1240566D 1240567D 1240956D 1241215D 1241521D 1241522D 1242146D 1242147D 1242164D 1242265 1242265D 1242266 1242266D 1242268D 1242271D 1242655 1242655D 1242656 1242656D 1242657 1242657D 1242658 1243272 1243272D 1243273 1243811 1243812 1244696 1244697 1244697D 1244698 1244699 1245106 1245107 1245107D 1340222 1340222D 1340223 1340223D 1340224 1340225 1340226 1340226D 1340710 1340710D 1341450 1341451 1341452 1341452D 1341453 1341454 1341455 1341455D 1341456 1341850D 1342210 1342211 1342211D 1342212 1342212D 1342214 1342215 1342215D 143465B 1440348 1440349 1440350 1440351 1440352 1441655 151299 180899 2706R 372499 401299 512498 
Recalling Firm/
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact
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.