Stryker Recalls Thoracic Pedicle Feelers Due to Potential Tip Breakage
Stryker is voluntarily recalling 28 Thoracic Pedicle Feelers because machine settings caused material degradation, creating a risk that the instrument tip may break.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of physical failure (tip breakage) during a surgical procedure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling 28 units of the Stryker Thoracic Pedicle Feeler (model 6002-350-000). These smart instruments are used in conjunction with the Stryker Navigation System to create a pathway into the pedicle and control navigation software. The affected units were distributed internationally, in the US, and to US Government entities.
The recall is being issued because the settings on the machine were higher than intended. This error led to increased energy being directed onto the tip of the Thoracic Pedicle Feeler, which caused material degradation at the laser-marked intervals. As a result, there is a potential for the tip of the instrument to break during use.
The affected serial numbers are 10897 through 10928, with specific exclusions noted in the official record. The Product Code (UDI) is (01)04546540503824. Users of these devices should stop using the affected instruments and contact Stryker for further instructions on the recall process.
The recalled product
- 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 Ped
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 28
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Number(s) Affected: 10897
- 10898
- 10899
- 10900
- 10901
- 10902
- 10903
- 10904
- 10905
- 10906
- 10907
- 10908
- 10909
- 10910
- 10911
- 10912
- 10913
- 10914
- 10917
- 10919
Distribution
Distribution scope not specified by the agency.
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