Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
An OrthAlign knee-system recall does not prove the same defect in another product, but it does justify a documented orthopedic workflow assessment instead of premature closure.
If you manufacture electrosurgical instruments or any device with welded metal components from external suppliers, this recall creates a specific question: could the same supplier validation gap exist in your supply chain?
If you manufacture electrosurgical instruments or any device with welded metal components from external suppliers, this recall creates a specific question: could the same supplier validation gap exist in your supply chain?
Enter your device and see what needs review