Recall Z-0653-2015— Stryker Endoscopy

Class II FDA medical device recall by Stryker Endoscopy, initiated 2014-11-17, terminated 2015-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. 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: 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.

Recalling firm

Stryker Endoscopy

Classification

Class II

Status

Terminated

Initiated

2014-11-17

Terminated

2015-07-17

Firm location

San Jose, CA, United States

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