Synthes voluntarily removes N-Hance spine fusion system from the US market

Synthes Packs Up N-Hance in U.S. (OTW)

Synthes Spine is not waiting for a warning letter from the FDA regarding the company’s requirement to submit an overdue postmarket surveillance study plan for the N-Hance Fusion System.

Instead the company has decided to voluntarily withdraw the device from the U.S. market. This adds another layer to the regulatory debate about the FDA’s impact on medical device innovation in the U.S.