Z-1216-2018Class II

The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation...

Name: Z-1216-2018 The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2017-10-16
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-10-16 / Terminated / root cause: software

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2017-10-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1216-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-16
Posted: 2018-03-27
Terminated: 2019-04-03
Recalling firm: Stryker Corp.
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 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.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: 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.
Quantity in commerce: 28
Distribution: International , US and US Govt.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1216-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1216-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code HAW

K012380Class IIModification to: Stryker Navigation System, Stryker Fluoroscopy System,virtual FluoroscopyStryker Leibinger / cleared 2001-12-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)