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.
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.
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.
The instrument's settings were higher than intended, causing increased energy to be directed onto the tip. This led to material degradation at the laser-marked areas, where the tip could break during use.
Surgical professionals who use the Stryker Thoracic Pedicle Feeler 6002-350-000 with the Stryker Navigation System are most at risk. Patients undergoing spinal surgery may be affected if the instrument breaks during procedure.
Check for serial numbers 10897 through 10928 on the instrument. The product code (UDI) is (01)04546540503824.
Look for serial numbers 10897 through 10928 on the Thoracic Pedicle Feeler.
Reach out to Stryker directly to confirm if your instrument is affected and get instructions for next steps.
The settings on the machine were higher than intended, causing increased energy directed onto the tip, which led to material degradation and potential tip breakage.
The tip could break during use, which may cause injury to the patient or surgical professional.
Check for serial numbers 10897 through 10928 on the Thoracic Pedicle Feeler.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1216-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1216-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
