PKG, DEBANEY FORCEPS, P/N 0250080314. 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.
This recall has been terminated (originally issued December 12, 2014).
- Company
- Stryker Endoscopy
- Recall Initiated
- November 17, 2014
- Posted
- December 12, 2014
- Terminated
- July 17, 2015
- Recall Number
- Z-0676-2015
- Quantity
- 180,573 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
143177 143178 246074 344739 444155 644081 645995 647106 647107 647111 647115 647116 647119 647121 647122 647123 647124 647125 647126 846997 940698 940700 940701 940702 940706 940707 940708 940709 940713 940714 940715 940717 940721 940722 940723 940724 943750 943862 1045977 1045978 1045979 1045980 1046707 1141928 1141929 1143434 1143435 1144968 1145466 1145467 1240129 1240549 1242018 1242851 1242852 1243860 1243861 1244476 1244788 1245555 1245556 1245969 1246404 1246406 1340287 1340723 1340724 1342682 1342842 1342843 1342844 1343524 1343525 1343989 1343990 1344458 1346205 1440786 1441077 1441462 1442554 1443205 644082
Root Cause
Error in labeling
Action Taken
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.