UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 13, 2017
ZIMMER BIOMET HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-16407 | 13-4151777 | ||
(State or other jurisdiction | (Commission | (IRS Employer | ||
of incorporation) | File Number) | Identification No.) |
345 East Main Street
Warsaw, Indiana 46580
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code: (574) 267-6131
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter) ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(e) of the Exchange Act ☐
Item 8.01 | OTHER EVENTS |
Zimmer Biomet Holdings, Inc. issued a press release on June 13, 2017 announcing the resolution of the FDA Warning Letter related to its Zhejiang, China manufacturing facility. A copy of the press release is attached hereto as Exhibit 99.1 and the information set forth therein is incorporated herein by reference and constitutes a part of this report.
Item 9.01 | FINANCIAL STATEMENTS AND EXHIBITS |
(d) | Exhibits |
Exhibit No. |
Description | |
99.1 | Press Release, dated June 13, 2017, issued by the Registrant |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: June 13, 2017
ZIMMER BIOMET HOLDINGS, INC. | ||||
By: | /s/ Chad F. Phipps | |||
Name: | Chad F. Phipps | |||
Title: | Senior Vice President, General Counsel | |||
and Secretary |
EXHIBIT INDEX
Exhibit |
Description | |
99.1 | Press Release, dated June 13, 2017, issued by the Registrant |
Exhibit 99.1
345 E. Main St.
Warsaw, IN 46580
www.zimmerbiomet.com
Contacts:
Monica Kendrick | Matt Abernethy | |
574-372-4989 | 574-371-8042 | |
monica.kendrick@zimmerbiomet.com | matt.abernethy@zimmerbiomet.com | |
Barbara Goslee | ||
574-371-9449 | ||
barb.goslee@zimmerbiomet.com |
Zimmer Biomet Holdings Announces Resolution of
FDA Warning Letter Related to Its Zhejiang, China Manufacturing Facility
(WARSAW, IN) June 13, 2017Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the Warning Letter dated June 3, 2015 relating to its Zhejiang, China manufacturing facility has been closed out.
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, said David Dvorak, Zimmer Biomets President and Chief Executive Officer. 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.
About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic
reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.
Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomets expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomets filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.