Smith & Nephew Hit With Warning Letter Over Morcellators

The FDA warning letter involves the London-based multinational's Andover, MA, plant, and brings up a number of issues.

Nancy Crotti

FDA has issued a warning letter to Smith & Nephew, citing inadequate quality control measures with the Truclear Ultra 4.0 Reciprocating Morcellators made at its Andover, MA, plant.

Following a March inspection of the facility, FDA concluded that the company couldn't prove it had corrected issues regarding complaints of loss of visualization with the morcellators and about the devices' sluff chambers being too small.

FDA also claimed the plant violated company procedures by releasing morcellators it had put on product hold in 2012 before completing a health hazard assessment. The company also released "reworked" reciprocating morcellators without evaluating the effects of ethylene oxide sterilization on the devices, the letter said.

An April 16, 2015, a company response to FDA said the morcellators were on hold.

The agency said Smith & Nephew failed to:

FDA warned the company to correct the alleged violations or face the consequences.

"Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," it said. "These actions include, but are not limited to, seizure, injunction, and civil money penalties."

London-based Smith & Nephew said the following in an email response to Qmed:

"We are currently drafting a response and are committed to working with the FDA to resolve all of the issues identified. There have been no issued field actions, recalls, or seizures demanded by FDA as a result of the 483 observations and/or Warning Letter. We are confident that the necessary actions are underway to deliver these improvements."

Nancy Crotti is a contributor to Qmed and MPMN.

Like what you're reading? Subscribe to our daily e-newsletter.