The Stryker Thoracic Pedicle Feeler 6002-350-000 is a recall: Impurity Out of Spec
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…
Why was The Stryker Thoracic Pedicle Feeler 6002-350-000 is a recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 28
- Distribution
- International , US and US Govt.
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)