Encore Medical, LP is recalling 836 units of Altivate Reverse Torx Peripheral Screws because the packaging identifies a different size than the screw actually contained inside. These screws are part of shoulder replacement systems intended to restore mobility and reduce pain. Because the labeling is incorrect, a surgeon might inadvertently select and use the wrong size screw during a procedure. If you have had shoulder surgery involving these implants, contact your healthcare provider for more information. No incidents or injuries have been reported to date.
Incorrect sizing labels on the packaging can lead to the use of an inappropriate screw size during shoulder surgery. This error could result in surgical delays while the correct part is located or complications related to an improper fit of the implant components.
Corrective action for clinical device
Quantity: 36 units
Quantity: 200 units
Quantity: 400 units
Quantity: 200 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 ยท 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.