Home / Recalls / Stryker Endoscopy / Z-0632-2015

Z-0632-2015 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, CLAW FORCEPS, P/N 0250080244. 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

542920 744855 745487 747207 842094 846779 847453 940070 940790 942064 942847 943550 944301 945449 1040412 1042233 1042680 1042689 1042701 1045852 1046704 1141030 1141031 1142001 1142002 1144327 1144623 1145082 1145339 1145978 1146685 1146993 1147101 1240120 1240538 1240539 1241480 1241481 1242392 1242393 1242923 1242924 1244171 1244172 1245446 1245447 1246063 1246064 1341588 1341589 1341590 1343694 1346228 1346669 1440891

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-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)
  • Z-0705-2015 Class II — PKG,5MM 45CM INSERT,PERFORATOR, P/N 0250080578S1 Laparoscopic Manual Instrument (November 17, 2014)
  • Z-0653-2015 Class II — PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instrumen (November 17, 2014)
  • 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)