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Synthes Inc. In Trouble Over Medical Device Complaint Reporting

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Synthes Inc. was presented with a warning letter from the FDA last month in regards to a procedures complaint at its West Chester, Pa. facility.

The letter accused the facility of failing to establish and maintain procedures for receiving complaints. Some complaints over products, such as rods, didn’t receive follow-up treatment in a timely manner, the letter said, and Synthes also missed the FDA’s 30-day deadline to file reports of device malfunction on several instances.

According to the FDA, the failure to quickly correct violations may lead to regulatory action. Synthes had 15 business days to respond, according to the letter dated Feb. 16.

According to Reuters, the FDA found the violations during an inspection carried out June 22 through Sept 15 of last year. The FDA said Synthes responded to its initial complaints on Sept. 29 but there was no evidence that the company had corrected the problems.

Synthes, which is in the process of being bought by Johnson & Johnson, makes artificial spinal disc implants and other products used in spine surgery. They also make plates, screws and rods used to repair the bones of trauma patients.

Synthes’ manufacturing issues come after Johnson & Johnson had its own series of high-profile product recalls and quality control problems with products such as infant Tylenol and artificial hips. disclaimer: This article: Synthes Inc. In Trouble Over Medical Device Complaint Reporting was posted on Wednesday, March 7th, 2012 at 10:50 pm at and is filed under Uncategorized.

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