The US Food and Drug Administration (FDA) has asked pharma giant Johnson & Johnson's DePuy Orthopaedics Inc to stop selling its Coral Hip System for unapproved uses and to provide information needed for the agency to approve the TruMatch software.
The FDA's warning letter, addressed to DePuy President David Floyd, was posted on the agency's website on Tuesday. The letter is dated Aug. 19. It is signed by Timothy A. Ulatowski, director of the Office of Compliance in the FDA center that oversees medical devices.
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The FDA states that the Corail Hip System is approved for total hip replacement in patients with six specific types of damage to the hip. But a brochure on DePuy website claims the system can be used for treating two other conditions.
"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 in the letter. "These actions include, but are not limited to seizure, injunction, and or civil money penalties."
As for the TruMatch System, it uses software and high-tech CT scanning technology to create a detailed, 3-D view of a patient's knee so a surgeon can properly position a knee implant.
"A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law," the FDA said in the letter.
"The FDA will evaluate the information you submit and decide whether your product may be legally marketed," stated the letter.
On Monday, Johnson & Johnson issued its ninth product recall in a year, this one covering millions of 1 Day Acuvue TruEye contact lenses sold in Japan and two dozen other countries in Asia and Europe. The recall followed complaints from customers in Japan of an unusual stinging or pain when inserting the lenses. Johnson & Johnson's Vision Care Inc. business blamed the failure of manufacturing equipment that rinses off substances used in producing the lenses, AP reports.
Johnson & Johnson already is under scrutiny by FDA officials, Congress and federal prosecutors over eight previous U.S. recalls of nonprescription medicines since last September. Those included millions of bottles of Tylenol, other pain relievers and cold medicines for children and adults.
The recalls have involved problems ranging from bacterial contamination and a nauseating smell on containers to drugs that may have the wrong amount of active ingredient and liquid medicines that may contain tiny metal shavings.
A DePuy Orthopaedics spokeswoman said Tuesday that the company has received the warning letter.
"We are reviewing the letter to understand the FDA's concerns and will respond to their request for information," she said by email.
Source: Medindia
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As for the TruMatch System, it uses software and high-tech CT scanning technology to create a detailed, 3-D view of a patient's knee so a surgeon can properly position a knee implant.
"A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law," the FDA said in the letter.
"The FDA will evaluate the information you submit and decide whether your product may be legally marketed," stated the letter.
On Monday, Johnson & Johnson issued its ninth product recall in a year, this one covering millions of 1 Day Acuvue TruEye contact lenses sold in Japan and two dozen other countries in Asia and Europe. The recall followed complaints from customers in Japan of an unusual stinging or pain when inserting the lenses. Johnson & Johnson's Vision Care Inc. business blamed the failure of manufacturing equipment that rinses off substances used in producing the lenses, AP reports.
Johnson & Johnson already is under scrutiny by FDA officials, Congress and federal prosecutors over eight previous U.S. recalls of nonprescription medicines since last September. Those included millions of bottles of Tylenol, other pain relievers and cold medicines for children and adults.
The recalls have involved problems ranging from bacterial contamination and a nauseating smell on containers to drugs that may have the wrong amount of active ingredient and liquid medicines that may contain tiny metal shavings.
A DePuy Orthopaedics spokeswoman said Tuesday that the company has received the warning letter.
"We are reviewing the letter to understand the FDA's concerns and will respond to their request for information," she said by email.
Source: Medindia
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