FDA Warns J&J’s DePuy Orthopaedics About Custom Devices

Johnson & Johnson Pulls Medical Devices

In a warning letter dated December 8th, federal health regulators warned Johnson & Johnson’s DePuy Orthopaedics unit that several of its hip, knee and joint replacements were improperly marketed. In response to the FDA’s warning, DePuy has decided to stop selling all if its custom fitted devices.

In its letter, the U.S. Food and Drug Administration outlined that several of DePuy’s custom devices and their corresponding components needed new PMA (premarket approval) or 510(k) applications. The FDA also noted that DePuy did not adequately notify regulators that it would be distributing approximately 14 of its products as custom devices.

The FDA backed its claims by stating that the devices DePuy distributed were far too similar to its standard products to be considered “custom” devices. The products in question include those made for the knee, ankle and hip.

According to a statement released by a DePuy spokesperson, the company now plans to address all quality issues cited in the FDA’s warning letter.

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