On June 6, 2016, in a filing with the Securities and Exchange Commission, medical device maker Zimmer Biomet revealed that it had received a warning letter from the Food and Drug Administration in late May over non-conformities with good manufacturing practice requirements at its Montreal, Quebec facility.
Zimmer Biomet’s web site says, “We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.” Zimmer metal-on-metal hip replacement devices have been the subject of numerous lawsuits over early failures, patient injuries, and metal poisoning.
The FDA letter, based on a January inspection of the company’s facilities, cites quality assurance issues at the Quebec plant. The warning letter restricts the clearance of premarket approval applications for Class III devices that are affected by the quality system deviations. The company said that it has no such applications under consideration, MassDevice reports.
The warning letter “does not restrict production or shipment” of goods from the Montreal facility, nor does it require Zimmer Biomet to withdraw any current products from the market, according to Zimmer Biomet’s SEC filing.
Zimmer Biomet said it has “provided detailed responses to the FDA” explaining the corrective actions it has taken. The company added that it believes the issues cited in the warning letter can be “resolved without a material impact on the company’s financial results.” Until the violations are corrected, Zimmer Biomet may be subject to additional regulatory action by the FDA, according to the SEC filing.