Home / Recalls / Stryker Endoscopy / Z-0643-2015

Z-0643-2015 Class II Terminated

Recalled by Stryker Endoscopy — San Jose, CA

Recall Details

Product Type
Devices
Report Date
December 24, 2014
Initiation Date
November 17, 2014
Termination Date
July 17, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180,573 units

Product Description

PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. 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.

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 Pattern

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.

Code Information

444676 744850 747211 846766 847686 847689 940825 941062 941240 944702 945444 1040418 1042252 1042641 1042642 1046930 1141610 1142468 1143262 1143499 1144311 1144491 1145814 1146361 1241908 1242646 1243540 1246126 1246648 1340098 1340237 1341587 1341998 1342754 1342755 1343012 1343692 1345519 1346667 1441561 1441817 1442227 1443326 1444430 646004

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  • Z-0612-2015 Class II — PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. Laparoscopic Manual Inst (November 17, 2014)
  • Z-0601-2015 Class II — PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instrum (November 17, 2014)
  • Z-0731-2015 Class II — PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 Laparoscopic Manual Instruments a (November 17, 2014)
  • Z-0762-2015 Class II — PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 Laparoscopic Manual In (November 17, 2014)
  • Z-0769-2015 Class II — PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM, P/N 0250282011 Laparoscopic Ma (November 17, 2014)
  • Z-0749-2015 Class II — PKG, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 Laparos (November 17, 2014)
  • Z-0614-2015 Class II — PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. Laparoscopic Manual Ins (November 17, 2014)
  • Z-0714-2015 Class II — PKG, 5MM SHAFT, NEEDLE HOLDER CURVED LEFT 45CM, P/N 0250080589 Laparoscopic Man (November 17, 2014)