The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart… recallZ-1216-2018 · Stryker Instruments Div. of Stryker Corporation · initiated Oct 16, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Instruments Div. of Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
US customers will be notified via FedEx overnight. US Sales Representatives will be notified via email. International entities will be notified via an internal notification system. International customers will be notified per local regulations/procedures. Customer Instructions: Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and discontinue use of any affected Thoracic Pedicle Feelers. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you don't have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. If the BRF for your facility indicates that recalled product is currently on hand, we will contact you to arrange for the return of the product for repair/replacement. If discontinuing use of the specific Thoracic Pedicle Feeler(s) listed will cause disruption at your facility. For further questions, please call (269) 323-7700.
Recall details
- Recall number
- Z-1216-2018
- Status
- Terminated
- Initiated by the company
- Oct 16, 2017
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 28
- Product code
- HAW
- FDA submissions
- K012380
- Distribution
- International , US and US Govt.
Product description
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 marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 6002-350-000Stryker Leibinger GmbH & Co. KG · Neurological stereotaxic Instrument1 recall50 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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