Home / Recalls / Stryker Endoscopy / Z-0601-2015

Z-0601-2015 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, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; 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

11065 12295 36062 38692 38692S 39653 39653Q 40941 41940 45715 47498 48553 53027 57438 59018 61549 65595 67460 68636 69943 71159 71690 72430 73104 73143 76287 78164 81388 82391 83206 84297

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-0612-2015 Class II — PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. Laparoscopic Manual Inst (November 17, 2014)
  • Z-0614-2015 Class II — PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. Laparoscopic Manual Ins (November 17, 2014)
  • Z-0731-2015 Class II — PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 Laparoscopic Manual Instruments a (November 17, 2014)
  • Z-0643-2015 Class II — PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. Laparoscopic Manual Instru (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-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-0714-2015 Class II — PKG, 5MM SHAFT, NEEDLE HOLDER CURVED LEFT 45CM, P/N 0250080589 Laparoscopic Man (November 17, 2014)