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Use caution Medical device recall · FDA · Published October 16, 2017

Stryker Thoracic Pedicle Feeler 6002-350-000 Recall: Potential Tip Breakage Risk

Stryker recalls specific Thoracic Pedicle Feelers (serials 10897-10928) due to potential tip breakage from material degradation. Learn what to do if you own this instrument.

🇺🇸 FDA recall #Z-1216-2018Medical deviceStryker ›
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Recalling firmStryker Instruments Div. of Stryker Corporation4100 E Milham Ave · Portage, MI 49002-9704
✎ GovInfoNow plain-language explainer

Stryker is recalling certain Thoracic Pedicle Feelers used with their navigation system because higher settings caused material degradation. This could lead to the tip breaking during use, which may cause injury. Read more at govinfonow.com/recall/72838-stryker-thoracic-pedicle-feeler-6002-350-000-recall-potential-tip.

Source Summary by GovInfoNow · govinfonow.com/recall/72838-stryker-thoracic-pedicle-feeler-6002-350-000-recall-potential-tip · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1216-2018

Cite this page

“Stryker Thoracic Pedicle Feeler 6002-350-000 Recall: Potential Tip Breakage Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72838-stryker-thoracic-pedicle-feeler-6002-350-000-recall-potential-tip. Based on FDA recall #Z-1216-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2018%22&limit=1).

The FDA announced on Oct. 16, 2017, that Stryker Instruments Div. of Stryker Corporation is voluntarily recalling The Stryker Thoracic Pedicle Feeler 6002-350-000 due to the potential for the tip to break. This hazard stems from machine settings causing material degradation at laser marks.

How to tell if you have it

  • Brand: Stryker
  • Product: The Stryker Thoracic Pedicle Feeler 6002-350-000
  • UPC: 04546540503824
  • Serial Numbers: 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

The hazard

The FDA said the machine settings were higher than intended, leading to increased energy directed onto the tip of the Thoracic Pedicle Feeler. This caused material degradation where laser marks exist, creating a potential for the tip to break.

Context

GovInfoNow's records show Stryker Instruments Div. of Stryker Corporation has 11 other recalls on record since 2017-11-09. Other recent recalls include Stryker SurgiCount+ Software Version 2.0.17 (2022-06-15), Stryker Zyphr Disposable Cranial Perforator Recall (2020-10-16), and Stryker Neptune E-SEP 165mm Blade Electrode Recalled Due to Expired Product (2020-03-26). Other recent recalls of similar products include Stryker XCEL Bladeless Trocar W/Stability Sleeve 12x100mm Recall (2026-08-19), Stryker XCEL Bladeless Trocar W/Stability Sleeve 5x75mm Recall (2026-08-19), and Stryker XCEL Bladeless Trocar W/Optiview: Cracking Risk During Use (2026-08-19).

How to tell if you have this one

Check for serial numbers 10897 through 10928 on the instrument. The product code (UDI) is (01)04546540503824.

  • Brand
    Stryker
  • Product
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for serial numbers 10897 through 10928 on the Thoracic Pedicle Feeler.

  2. Contact Stryker

    Reach out to Stryker directly to confirm if your instrument is affected and get instructions for next steps.

How this recall unfolded

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Oct 16, 201712. FDA classified it Class II: Mar 27, 201823. Published in FDA’s Enforcement Report: Apr 4, 201834. FDA terminated the recall: Apr 3, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1216-2018 (October 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1216-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA