Medline Industries, LP has recalled 163 DEXLOCK Achilles Repair Implant Kits (model MAKT4520) due to reports of the drill bit fusing to the guide sleeve during surgery. When these components fuse together, surgeons must pause the operation to find a replacement drill bit and guide, which can prolong the surgical procedure. The recall specifically affects Lot 19019. If you are a healthcare professional, please check your surgical inventory to ensure these kits are removed from use.
The drill bit can become permanently stuck to the drill guide during use, making the tools inoperable. This failure requires the surgical team to stop and retrieve replacement equipment, potentially increasing the time a patient is under anesthesia and increasing the risk of surgical complications.
Recall #: Z-0911-2026. 163 units affected in the US.
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.