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FDA Issues Smith & Nephew Warning Letter Over Morcellator Quality Control Violations

The FDA has issued Smith & Nephew a warning letter for quality control violations at its Andover, MA, facility regarding problems with its Truclear Ultra Reciprocating Morcellator 4.0.

The U.S. Food & Drug Administration (FDA) has slapped Smith & Nephew with a warning letter for quality control violations at its Andover, MA, facility regarding problems with its Truclear Ultra Reciprocating Morcellator 4.0., a disposable blade that attaches to the Truclear Hysteroscope 8.0.

Free Smith & Nephew Morcellator Lawsuit Evaluation: If you or a loved one has been injured after undergoing laparoscopic power morcellation, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the morcellator and our lawyers can help.

What’s the Problem?

June 2, 2015 – Among the violations cited by the FDA 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 Smith & Nephew morcellator. The company has stopped distributing the instruments while it investigates the matter.

FDA said Smith & Nephew’s corrective action report lacked sufficient information to prove that the problem had been resolved, and that the company continues to receive complaints even though the issue was first raised nearly 3 years ago. The letter also says S&N removed a previous hold on the morcellator in 2012 before completing its review of complaints, in violation of the company’s own policy.

Other findings cited by the FDA:

  • Incorrect translation of the instructions for use of the TwinFix Ultra Preloaded Suture Anchors used to secure sutures or stitches in place;
  • Failure to document required tasks following complaints of breakage of the Beaver Blade device (a disposable blade used during hip surgery);
  • Failure to test the effect of some sterilization cycles on the Truclear Ultra Reciprocating Morcellators, and
  • Failure of Smith & Nephew to conduct internal audits at the Andover facility, violating its own policy.

FDA inspected the plant between March 4 and March 26, 2015. It says S&N has hired additional employees to assist with audit functions and conduct re-audits.

“These corrective actions appear adequate to address the violation. In response to this Warning Letter, please inform us of when these actions have been completed,” the letter said. “Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”

Do I Have a Smith & Nephew Morcellator Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Smith & Nephew power morcellator lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Morcellator Lawsuit Evaluation: Again, if you or a loved one was injured after having surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellator Suit and our lawyers can help.

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