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.

RESULTS & SETTLEMENTS

Frank M. Eidson P.A. has been tirelessly representing the rights of Central Florida victims since 1989.

$1.2 Million

Two surgeries for back injuries.

$1 Million

Fell from a roof while working.

$1.15 Million

Brain injury in a tractor-trailer crash.


Free, No Obligation Case Review.

Fill out our contact form below for your free, no obligation case review.

  • This field is for validation purposes and should be left unchanged.
Help provide wounded servicemen and women with therapeutic outdoor adventures. Like our Facebook page and we'll contribute $1 to Wounded Warriors Outdoors.

Contact Our Orlando Attorney

If you have been injured in an accident, turn to Frank M. Eidson P.A. Whether your case is a simple collision or a complicated auto wrongful death case, contact personal injury lawyer Frank Eidson today to schedule your free consultation.

407-245-2887