By Varun Saxena
The FDA slapped Smith & Nephew ($SNN) with a warning letter for quality-control violations at its Andover, MA, facility related to problems with some of the company’s mechanical morcellators for removal of intrauterine tissue. The company has placed a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigates customer complaints.
Among the violations are a “failure to establish and maintain procedures for verifying or validating corrective and preventive actions” following complaints of loss of visualization when using the Truclear Ultra Reciprocating Morcellator 4.0.
The FDA said the company’s corrective action report about the problem contained insufficient information to prove that the issue had been resolved, and said the company continues to receive complaints about the problem even though the issue was first raised in September 2012. The letter also says that S&N removed a prior hold on the morcellator in 2012 before completing its review of the complaints, in violation of the company’s own policy.