Research Desk Line-up: Syneron Medical Post Earnings Coverage

LONDON, UK / ACCESSWIRE / June 15, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Warsaw, Indiana based Zimmer Biomet Holdings, Inc. (NYSE: ZBH). The Company announced on June 13, 2017, that the US Food and Drug Administration (FDA) has issued a Close Out letter with regards to the Warning Letter issued by the agency on June 03, 2015, and closed the Company's manufacturing unit in Zhejiang, China. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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The FDA had issued the close out letter on May 08, 2017, after completing the evaluation of the facility in China and finding that the violations raised in the Warning Letter were successful addressed and conformed to the FDA's rules and guidelines.

Commenting on the matter, David Dvorak, President and CEO of Zimmer Biomet said:

"The successful clearance of the Warning Letter related to our Zhejiang, China manufacturing facility is a measure of the progress we have made in our ongoing quality and operational excellence journey. Zimmer Biomet takes seriously its responsibility to support surgeons and their patients, and the Company will continue to take the necessary actions to demonstrate our commitment to quality excellence, patient safety, and regulatory compliance."

Backdrop

In January 2015, the FDA had conducted an inspection of Zimmer Biomet's manufacturing unit located at Jinhua City, Zhejiang, China. This unit manufactured orthopedic surgical instruments used for knee prosthesis systems and were classified as devices as per the FDA rules. The inspection lasted from January 19, 2015, till January 22, 2015. The FDA found that the devices did not conform to good manufacturing practice requirements.

Zimmer Biomet had provided a response to the issues raised by the FDA in February 2015. The FDA studied the Company's responses and requested additional information to allow the agency to evaluate their adequacy.

The FDA issued the Warning letter on June 03, 2017, related to the observed non-conformities. Due to the FDA's warning letter and till such time that the violations were not corrected, the requests for Certificates to Foreign Governments related to products manufactured at Zhejiang facility could not get premarket approval applications for the devices as they did not meet the quality system regulation (QSR) of FDA.

The FDA had requested Zimmer Biomet to share the future plan of action giving details as to how the Company planned to prevent these violations from occurring again and documentary evidence supporting the corrective actions taken.

After nearly two years, on May 08, 2017, the FDA sent a close out letter after evaluating Zimmer Biomet's action report on the steps taken to address the violations indicated in the Warning Letter.

About Zimmer Biomet

Zimmer Biomet was founded in 1927 and is a global leader in musculoskeletal healthcare. The current avatar of the Company is the result of Zimmer Holdings, Inc.'s acquisition of Biomet in June 2015 after which the combined entity changed its corporate name to Zimmer Biomet Holdings, Inc. The Company designs, manufactures, and markets orthopaedic reconstructive products, sports medicine, biologics, extremities and trauma products, office based technologies, spine, craniomaxillofacial and thoracic products, dental implants and related surgical products. The Company's operations are spread across 25 countries and its products are sold in more than 100 countries across the world.

Last Close Stock Review

On Wednesday, June 14, 2017, the stock closed the trading session at $125.60, slightly rising 0.10% from its previous closing price of $125.47. A total volume of 803.40 thousand shares have exchanged hands. Zimmer Biomet's stock price rallied 4.97% in the last three months, 18.70% in the past six months, and 7.52% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have surged 21.71%. The stock is trading at a PE ratio of 51.41 and has a dividend yield of 0.76%. At Wednesday's closing price, the stock's net capitalization stands at $25.16 billion.

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