Zimmer Biomet Reveals FDA Warning Letter Received In May
July 28, 2016 at 4:25 p.m.
By Staff Report-
The letter, which came based on a January inspection of the company’s facilities, restricts the clearance of premarket approval applications for Class III devices, which are affected by the quality system regulation deviations. The company said that it has no such applications.
The letter “does not restrict production or shipment” of goods from the Montreal facility, nor does it require any withdrawal of any current products from the market, according to an SEC filing from the company, massdevice.com reports.
Zimmer Biomet said it has “provided detailed responses to the FDA” explaining the corrective actions it took, and added that it believes the warning letter can be “resolved without a material impact on the company’s financial results.”
According to massdevice.com, a response from the FDA could not be guaranteed, and the company warned that until the violations are corrected, it “may be subject to additional regulatory action by the FDA.”
In May, Zimmer Biomet said it closed its buyout of Cayenne Medical and its soft tissue reconstruction devices for an unspecified amount.
Scottsdale, Ariz.-based Cayenne makes devices for knee and shoulder repair, including the AperFix II, CrossFix II and iFix knee ligament reconstruction and meniscal repair devices and the Quattro device for rotator cuff and labral repairs.[[In-content Ad]]
The letter, which came based on a January inspection of the company’s facilities, restricts the clearance of premarket approval applications for Class III devices, which are affected by the quality system regulation deviations. The company said that it has no such applications.
The letter “does not restrict production or shipment” of goods from the Montreal facility, nor does it require any withdrawal of any current products from the market, according to an SEC filing from the company, massdevice.com reports.
Zimmer Biomet said it has “provided detailed responses to the FDA” explaining the corrective actions it took, and added that it believes the warning letter can be “resolved without a material impact on the company’s financial results.”
According to massdevice.com, a response from the FDA could not be guaranteed, and the company warned that until the violations are corrected, it “may be subject to additional regulatory action by the FDA.”
In May, Zimmer Biomet said it closed its buyout of Cayenne Medical and its soft tissue reconstruction devices for an unspecified amount.
Scottsdale, Ariz.-based Cayenne makes devices for knee and shoulder repair, including the AperFix II, CrossFix II and iFix knee ligament reconstruction and meniscal repair devices and the Quattro device for rotator cuff and labral repairs.[[In-content Ad]]
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