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

Class 2 Device Recall PKG, SPRING HANDLE

  • 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, SPRING 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-0627-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
Product PKG, SPRING HANDLE, P/N 0250080237.
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 413144 414465 614433 716055 717057 717566 913220 913565 913566 913625 913763 914558 914559 914560 914654 914655 915026 915062 915269 915270 915430 915791 915895 1013200 1013201 1013277 1013393 1014635 1015163 1015164 1015774 1015863 1016125 1016405 1016407 1016555 1016556 1113333 1113334 1113335 1113340 1114205 1114544 1114545 1114546 1115529 1115530 1115650 1115652 1115653 1116111 1116113 1116460 1116461 1117176 1117177 1213128 1213258 1213259 1213973 1213975 1214001 1214735 1214736 1215298 1215299 1216023 1216024 1216228 1216229 1216288 1216721 1216722 1313330 1313331 1313332 1313805 1313806 1313947 1313948 1313972 1314203 1314204 1314472 1315785 1315786 1315787 1410413 
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.
-
-