FDAOctober 16, 2017device

The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.

What to do

FDA enforcement status: Terminated

Brands named

stryker instruments divstrykerstryker instruments

UPCs

04546540503824

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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