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
© Copyright ASC COMMUNICATIONS 2012. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.
To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.
New from Becker's ASC Review
5 Recent Articles on ASC Supplies & ManagementRead Now
- 12 ASCs With Innovative Cost-Cutting Initiatives
- MEDNAX acquires Associated Anesthesiologists of Joliet, 3 related entities
- Oregon Outpatient Surgery Center first ASC in Northwest to perform total hip replacement: 3 things to know
- Orlando Health, USPI partner in ownership of University Surgical Center
- Ophthalmologist Dr. Glenn Campbell to open single-specialty Virginia ASC