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Recall Observatory FDA recall evidence

Device product

PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 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.

Z-0740-2015

November 17, 2014

Class II

Product summary

Firm
Stryker Endoscopy
Event
Event 69838
Status
Terminated
Classification
Class II
Quantity
180,573 units total
Official record key
device-enforcement:Z-0740-2015

Official wording

Reason: 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

Code information: 746661 842498 940096 940141 943492 943738 944195 944819 1040538 1042104 1042442 1042910 1042911 1045074 1045848 1141786 1142613 1144393 1240140 1241903 1242135 1242925 1244593 1245032 1245544 1246160 1341518 1342003 1342747 1343305 1343422 1343727 1346658 1440420 1440479 1440957 1441379 1442622 1442788 1443586

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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