In January, the FDA sent a letter warning Johnson & Johnson subsidiary DePuy that a dozen devices are unapproved or need a new 510(k) approval and the company must take steps to recall unused products.
In the days following the FDA’s release of the warning letter, DePuy immediately stopped production of all custom implants, not just those detailed in the warning letter. DePuy has sold more than 8,300 custom implants since 1999. The company is now recalling unused units.
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