FDA Issues Warnings to Biomet and DePuy

Two orthopedic giants recently have been flagged for improperly marketing devices that the U.S. Food and Drug Administration (FDA) claims it has not cleared.

The FDA recently warned Warsaw, Ind.-based Biomet that its Signature Personalized Patient Care system, a pre-operative surgical planning offering for knee replacement procedures, has not been cleared by the agency for marketing in the United States.

In a warning letter sated July 27, the FDA said the system, which uses MRI and CT scans to develop a pre-operative plan for implanting Biomet’s Vanguard knee replacement, does not have premarket approval, an investigational device exemption or 510(k) clearance.

Biomet replied to the warning letter on August 3, “explaining why the company believes that the Signature Personalized Patient Care system, which is manufactured by Materialise NV, has been appropriately marketed under a 510(k) premarket clearance.”

Biomet officials released a statement saying they are “committed to working with the FDA to resolve the issue in the best interests of patients and their doctors without disruption to patient treatment.”

In addition, Johnson & Johnson’s DePuy Orthopaedics division was notified that it is selling a product never approved for sale and yet another for uses that have not been specifically approved.

The FDA wrote in a letter that DePuy, also based in Warsaw, illegally is marketing its TruMatch Personalized Solutions system because it hasn’t received appropriate clearance to sell the product. Additionally, the FDA found that DePuy is promoting its Corail Hip System for uses that haven’t yet been approved. The FDA added that the Corail Hip System has been misbranded and asked DePuy to immediately stop marketing the Corail system for unapproved uses.

“Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice,” the agency said wrote. “These actions include, but are not limited to seizure, injunction, and or civil money penalties.”

A DePuy officials said the currently are reviewing the letter, “understand the FDA’s concerns” and will respond to their request for information.