Spineart SA has recalled 16 units of Perla TL MIS Cannulated Fenestrated Polyaxial Screws because they may be incorrectly labeled. The recall affects specific catalog models MPF-PS 65 40-S and MPF-PS 55 45-S. Because these devices are surgical implants, healthcare providers should immediately identify and isolate any affected products to prevent their use in medical procedures. If you are a patient and believe you may have received one of these implants, contact your healthcare provider for further information.
Incorrect labeling on surgical screws can lead to a surgeon selecting and implanting the wrong device during surgery. This can cause surgical delays, the need for additional procedures, or medical complications if the incorrect hardware is used.
Quantity affected: 16 units.
Quantity affected: 0 units distributed (per API data).
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.