Home / Recalls / Stryker Endoscopy / Z-0705-2015

Z-0705-2015 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,PERFORATOR, P/N 0250080578S1 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

345340

Other recalls by Stryker Endoscopy

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  • Z-1831-2015 Class II — SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes (June 3, 2015)
  • Z-0787-2015 Class II — PKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instrum (November 17, 2014)
  • Z-0782-2015 Class II — PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic M (November 17, 2014)
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  • Z-0618-2015 Class II — PKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. Laparoscopic Manual Instrumen (November 17, 2014)
  • Z-0595-2015 Class II — PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instr (November 17, 2014)
  • Z-0761-2015 Class II — PKG, 3MM INSERT, FUNDUS GRASPER, 20CM, P/N 0250282003 Laparoscopic Manual Instr (November 17, 2014)
  • Z-0741-2015 Class II — PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instrum (November 17, 2014)