1. Medtronic on Jan. 6 issued a Class I recall of the company’s Synergy Cranial and StealthStation S7 Cranial software. The recall affects devices manufactured between May 1, 2019, and Oct. 29, 2021. Nearly 950 devices in the U.S. are affected. The FDA identified this as a Class I recall, indicating the product could cause serious injury or death. The recall was issued because of potential inaccuracies with the Biopsy Depth Gauge Cycle View. Four complaints have been filed regarding the issue, and there have been no reported injuries or deaths.
2. Exactech recalled 40,000 hip implants in August. The implants are being recalled over the failure of polyethylene liners, which could have been degraded due to oxygen exposure from nonconforming packaging. More than 250,000 recalled Exactech joint devices have been implanted in the U.S., including knee and ankle implants that were recalled in 2021 and February 2022. The latest recall of hip implants includes the Acumatch GXL; the Novation GXL and MCS GXL; Exactech All Polyethylene Cemented Cup; Acumatch Conventional UHMWPE; MCS Conventional UHMWPE; and the Novation Conventional UHMWPE.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
