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U.S. Department of Health and Human Services

Class 2 Device Recall PKG, MARYLAND FORCEPS, CURVED LEFT

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  Class 2 Device Recall PKG, MARYLAND FORCEPS, CURVED LEFT 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-0652-2015
Recall Event ID 69838
Product Classification Endoscope and/or accessories - Product Code KOG
Product PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282.
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 43967 140297 246217 340634 341506 341508 344540 344549 444519 05242012E 542134 641033 641039 646904 646920 646927 646929 647553 741526 747007 747010 747012 747017 747023 747024 846041 846044 846048 846060 846061 846062 846080 941874 941876 941877 941878 941879 941880 941881 941885 941886 941887 941888 941889 941890 941894 941895 941897 941898 941899 941900 941904 941905 941906 942385 945570 945571 945572 945573 945574 945575 945576 945580 945581 945582 945585 945586 945587 945591 945592 945594 945595 945596 945597 945601 945602 945603 1045189 1045364 1045365 1045366 1045675 1045676 1045677 1045678 1045679 1046174 1046612 1046613 1140665 1140666 1140667 1140668 1140669 1141746 1141747 1142170 1142171 1142172 1142185 1142186 1142187 1142631 1142632 1143459 1143460 1143461 1143462 1143463 1143464 1143465 1144713 1144714 1144715 1144716 1144717 1144721 1145476 1145477 1146158 1146159 1146379 1146380 1146381 1146382 1146383 1146705 1146706 1146707 1146708 1146841 1146842 1147049 1147050 1147164 1147165 1147166 1147167 1147168 1147169 1147170 1240961 1240962 1241086 1241087 1241088 1241090 1241401 1241779 1241780 1241781 1241782 1241783 1241784 1241785 1241786 1241787 1241788 1242411 1242412 1243160 1243161 1245033 1245034 1245035 1245036 1245455 1245478 1245479 1245970 1245971 1245972 1340137 1340138 1340139 1340140 1340141 1340142 1340143 1340144 1340718 1340719 1340720 1341826 1341827 1341828 1341829 1341830 1341831 1341832 1342203 1342845 1342846 1343264 1343526 1343528 1343529 1343531 1344420 1440243 1440244 1440286 1442301 1443206 1443602 163699 641047 846044 941880 
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
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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