Several major medtech companies, including Stryker and Medtronic, have been the focus of musculoskeletal product recalls and warnings in 2024. Here are four major recalls and alerts from this year for spine and orthopedic leaders to know:
1. A Class I recall was issued for Medtronic's StealthStation System with StealthStation Cranial software, which is used for locating anatomical structures during neurosurgery. As of early June, Medtronic had received 28 complaints related to this issue, but no reported injuries or deaths. Medtronic issued the recall for devices distributed between March 21, 2017, and March 22, 2024.
2. Medtronic Neurosurgery issued a Class I recall affecting 45,176 Duet external drainage and monitoring system catheter tubing. Twenty-six injuries were reported as of March, but no related deaths.
3. Stryker recalled 143 units of its Triathlon total knee system because of issues affecting the inner blister and outside sterile blisters of the implant packaging.
4. 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, which can lead to faster device wear or failure and component cracking and fractures.