Which medical product recall in the 1970s led to the Medical Device Amendments of 1976, fundamentally changing FDA regulation of medical devices?

The pharmaceutical and medical device industries have faced numerous product recalls over the years, some with far-reaching consequences. These recalls not only impact patient safety but can permanently alter company reputations and transform industry regulations. This trivia question focuses on one of the most significant medical product recalls in history that changed how medical devices are regulated worldwide.

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The Dalkon Shield intrauterine device
Johnson & Johnson Tylenol tampering case
Boston Scientific Guidant defibrillators
Dow Corning silicone breast implants