# FDA recall Z-1216-2018

> **Stryker Instruments Div. of Stryker Corporation** · Class II · device recall initiated 2017-10-16.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1216-2018
- **Recalling firm:** Stryker Instruments Div. of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-16
- **Report date:** 2018-04-04
- **Termination date:** 2019-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2018

## Citation

> AI Analytics. FDA recall Z-1216-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1216-2018. Source: US FDA. Licensed CC0.

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