Here are five FDA alerts and recalls from 2024 for orthopedic and spine specialists to know:
1. The FDA issued a warning about the increased risk of thigh bone fractures post-surgery with the use of the Zimmer Biomet CPT Hip System. Zimmer Biomet issued a voluntary recall of the system on July 2 to update instructions and plans to phase out the sale of the device by December 2024.
2. A Class I recall was issued for Medtronic's StealthStation System with StealthStation Cranial software, which is used for locating anatomical structures during neurosurgery. Medtronic issued the recall for devices distributed between March 21, 2017, and March 22, 2024.
3. Stryker recalled 143 units of its Triathlon total knee system. The recalls were initiated because of issues affecting the inner blister and outside sterile blisters of the implant packaging.
4. Medtronic Neurosurgery issued a Class I recall affecting 45,176 Duet external drainage and monitoring system catheter tubing following 26 reported injuries. The recall impacted five product models.
5. The FDA issued a patient safety alert regarding Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and August 2021 due to a defect with the packaging. The defective bags used for packaging were missing an oxygen barrier layer that protects devices from oxidation.