Approximately 18,100 Frontier Devices Distraction Pins are being recalled because the product labeling includes a shelf life that has not been properly validated. The recall affects 12 mm, 14 mm, and 16 mm pins in various single and double pack configurations. These sterile surgical devices were distributed across several states between August 1, 2020, and July 30, 2025.
Using these medical devices beyond their unvalidated shelf life may compromise their sterility or mechanical integrity. This could increase the risk of surgical site infections or complications during orthopedic procedures.
All lots distributed within the date range are affected.
All lots distributed within the date range are affected.
All lots distributed within the date range are affected.
All lots distributed within the date range are affected.
All lots distributed within the date range are affected.
All lots distributed within the date range are affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.