A recent prominent recall that happened was part of Johnson & Johnson’s orthopedic subdivision Depuy Synthes. In this situation J&J was found negligent in properly informing consumers that their metal on metal hip implant (Pinnacle Hip implant) had a design flaw. The ASR hip implant was the first of the metal on metal hip implant’s recalled by Depuy in 2010 due to wear debris and high failure modes, this voluntary recall was initiated after data was received from the National Joint Registry of England and Wales indicated that patients were undergoing secondary hip replacement surgery much quicker than usual. After this voluntary hip implant recall in 2010, recently in late 2016 a jury found J&J guilty of negligence with the Pinnacle hip implant line, which had a similar design defect as that of the ASR line that was voluntary recalled in 2010. The cost that J&J incurred from the ASR line is estimated to be 2.5 billion dollars in settled lawsuits (7,000) and in early 2017 a group of 6 plaintiffs won 500 million dollars as a result of the Pinnacle hip implant defects. The main cause behind these design flaws making it past the FDA is the loophole in the 510(k) process which allows companies to skip the rigorous testing process in the guise of predicate devices, resulting in many patients suffering.

Sources
http://www.asrhipinfo.com/content/asr-hip-0
http://www.reuters.com/article/us-johnson-johnson-verdict/judge-halves-1-billion-award-in-jj-hip-implants-case-idUSKBN14O0DF