FDA Increases Severity of Stryker Knee Device Recall to Class 1
The ShapeMatch Cutting Guides are designed to assist with total knee replacement positioning. Originally, they were recalled because construction may not have been in accordance with preoperative planning parameters and without 510(k) approval, according to the report.
More Articles on Supply Chain:
31 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in March
Regentis Biomaterials Doubles Scope of Orthopedic Implant Trial
FDA Grants 510(k) Clearance to SterEOS Spine Imaging System
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