Home / Recalls / Stryker Endoscopy / Z-0737-2015

Z-0737-2015 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 total

Product Description

PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 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

647989 746662 746663 943683 1040537 1041465 1042439 1043520 1046696 1141788 1144224 1145794 1243095 1244521 1245019 1245817 1341521 1343008 1343551 1344031 1344277 1346244 1346420 1440412 1442624

Other recalls by Stryker Endoscopy

  • Z-1566-2016 Class II — PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High (March 28, 2016)
  • Z-1831-2015 Class II — SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes (June 3, 2015)
  • Z-0767-2015 Class II — PKG, 3MM INSERT, BLUNT GRASPER, 20CM, P/N 0250282009 Laparoscopic Manual Instru (November 17, 2014)
  • Z-0765-2015 Class II — PKG, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 Laparoscopic Manual Instru (November 17, 2014)
  • Z-0730-2015 Class II — PKG, ASPIRATION NEEDLE, 33CM, P/N 0250080702 Laparoscopic Manual Instruments ar (November 17, 2014)
  • Z-0736-2015 Class II — PKG, ASSY, 3.5MM PYRAMIDAL TROCAR, LONG P/N 0250080730 Laparoscopic Manual Ins (November 17, 2014)
  • Z-0650-2015 Class II — PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Inst (November 17, 2014)
  • Z-0784-2015 Class II — PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual Instr (November 17, 2014)
  • Z-0613-2015 Class II — PKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025. Laparoscopic Manual In (November 17, 2014)
  • Z-0779-2015 Class II — PKG, 3MM INSERT, FUNDUS GRASPER, 29CPKG, 3MM INSERT, ALLIGATOR GRASPER, 29CM, P/ (November 17, 2014)