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 ma
Check against the official notice below — it lists the full affected range.
Stryker Corporation is voluntarily recalling 28 Thoracic Pedicle Feelers (Model 6002-350-000) used with the Stryker Navigation System due to a manufacturing issue. The machines used to produce these instruments had settings that were higher than intended, causing increased energy to be directed at the tip of the feeler. This excessive energy resulted in material degradation at the locations where laser marks were made on the instruments.
The affected serial numbers are 10897 through 10928 (with some numbers excluded). The primary concern is that the tip of the Thoracic Pedicle Feeler may break due to the material degradation. The recalled instruments were distributed internationally, in the United States, and to U.S. government entities. The source does not specify what remedy affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: International , US and US Govt. Quantity: 28 Lot/code info: Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.