Last fall Kalamazoo, Mich.-based Stryker voluntarily urged physicians to discontinue use of its ShapeMatch orthopedic product, but recently the FDA upgraded the recall to a Class 1, indicating probability of serious health consequences or death, according to Michigan Live. 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 Devices:
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
More Articles on Devices:
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