K2M recalls fenestrated tap adapters (REF# 5001-90011) due to mislabeling. The product is intended for bone biopsy and spinal cement procedures but may be mislabeled, affecting safe use in medical settings.
The products are mislabeled.
K2M is recalling fenestrated tap adapters (REF# 5001-90011) because they are mislabeled. This could lead to incorrect use in medical procedures like bone biopsies or spinal cement injections, which are critical for patient safety.
The device is mislabeled, meaning it might be used for the wrong purpose. For example, it could be intended for bone biopsies but labeled as a cement dispenser, leading to improper use in spinal procedures.
Medical professionals who use the K2M Fenestrated Tap System for bone biopsies or spinal procedures may be affected. Patients undergoing these procedures are at risk if the device is mislabeled and used incorrectly.
Check for the product name 'Fenestrated Tap Adapter' and reference number REF# 5001-90011. The device is used in medical settings for bone biopsies and spinal cement procedures.
Look for the reference number REF# 5001-90011 on the device label to confirm it is part of the recall.
The recall is due to mislabeling, not safety issues. The device is intended for medical use but may be mislabeled, so it should be checked against the reference number.
Check the reference number on the device label. If it matches REF# 5001-90011, it is part of the recall and should be verified with the manufacturer.
The recall does not specify a need to stop use immediately. However, mislabeling could lead to incorrect use, so it's recommended to verify the device's intended purpose.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-1492-2019 — K2M K2M Hello, I own a K2M that is covered by recall Z-1492-2019 from K2M. 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.
