ETHICON, LLC is recalling 516 units of its STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Devices due to a defect where the device barbs may not engage with tissue properly. The recall affects product code SXPP2B400-11 from lot number 104DBB. These devices are used by healthcare professionals to control and secure tissue during surgical procedures.
If the barbs on the device fail to engage, the device may not be able to hold tissue together securely. This poses a risk of wounds re-opening after surgery or other complications that could require additional medical intervention.
Quantity affected: 516 units
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.