FDA Sends Zimmer Biomet’s ORTHOsoft Warning Letter

The FDA has sent Zimmer Biomet Holdings, Inc. a Warning Letter “related to observed non-conformities with current good manufacturing practice requirements of the Quality System regulation at the Company’s facility in Montreal, Quebec, Canada, ” according to a company June 6, 2016 8-K SEC filing.

The filing states the FDA inspected the facility in January 2016. The Montreal facility is the location of Zimmer Biomet’s wholly owned subsidiary, ORTHOsoft, Inc. (d/b/a Zimmer CAS – Computer Assisted Solutions). At the conclusion of the inspection, the FDA issued a Form 483, List of Inspectional Observations. The warning letter relates to the observations reflected in the Form 483.

The letter does not restrict production or shipment of products from the facility or require the withdrawal of any product currently in use. The letter also does not restrict the company’s ability to seek 510(k) clearance of products. “Until the violations have been corrected, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved. The Company presently has no such applications before the FDA, ” stated the filing.

The company says it has provided detailed responses as to its corrective actions since the conclusion of the inspection. The company also believes the FDA’s concerns can be resolved without a material impact on financial results.

Zimmer Holdings, Inc. acquired all of ORTHOsoft’s outstanding common shares in a 2007 cash transaction of approximately $50 million (Canadian dollars). Founded in 1995, ORTHOsoft developed medical software, instruments and computerized systems designed to help orthopedic surgeons increase accuracy in hip, knee and spine implant surgery.

At the time of the acquisition, Zimmer CEO Dave Dvorak said the acquisition would support Zimmer’s SmartTools strategic initiative and will allow the company to vertically integrate Zimmer’s Computer Assisted Solutions (CAS) efforts. CAS, also known as Surgical Navigation, is defined as a surgery that is performed using a computer as a guiding and validation tool. “The same way a car navigation system guides a driver from point A to point B, Zimmer’s surgical navigation system provides the surgeon with important information during a surgery, ” states the company’s website.

ORTHOsoft’s FDA-approved patented software solutions were developed to provide intuitive and easy-to-use navigation that tracks surgical flow and provides surgeons with real-time data, thus helping to improve the surgical process and patient outcomes. The company was selected in the “2006 TSX Venture 50, ” a ranking of the top emerging public companies listed on that exchange.