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Recall Observatory FDA recall evidence

Device product

PKG, MIXTER FORCEPS, P/N 0250080285. 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-0655-2015

November 17, 2014

Class II

Product summary

Firm
Stryker Endoscopy
Event
Event 69838
Status
Terminated
Classification
Class II
Quantity
180,573 units
Official record key
device-enforcement:Z-0655-2015

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: 41350 44269 442637 647415 743732 845623 846466 846767 847691 940788 941241 941606 942276 942920 943500 943533 945623 1040414 1041622 1042249 1042620 1042673 1042674 1042675 1046593 1047021 1140650 1142620 1143129 1144315 1144939 1145976 1146830 1240976 1242463 1244169 1246128 1246649 1341525 1341993 1342760 1343129 1346546 1346648 1440442 1442804

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