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FDA Classifies Synthes' Voluntary Medical Device Recall of Synex II Central Body Components as a Class I Recall
Download: Media Release
West Chester (PA), USA, November 4, 2009 Synthes (SWX: SYST.VX) announced today that the U.S. Food and Drug Administration (FDA) has classified a recall of Synthes Synex II Central Body components as Class I. This means that the product could impose an imminent hazard to health in patients.
The notification relates to a global voluntary recall of Synex II Central Body components on September 14, 2009, which was initiated after receiving six adverse event reports. These reports included moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery.
Synthes advises that surgeons and hospitals in possession of the subject devices must stop implanting them immediately. Physicians should contact Synthes for return instructions. Synthes further recommends annual monitoring of implanted patients by their physicians through radiographs and pain assessment. Radiographic changes and/or an increase in pain or other symptoms may be indicators of loss of device height and device failure. If patients have an increase in pain or other symptoms, they should contact their surgeons. This monitoring may or may not fall within Synex II surgeon users' routine postoperative care plan, and more frequent monitoring may be indicated depending on the patient's clinical profile.
The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).
Synthes notified hospitals and sales consultants of this recall through mail. The notification included identification of recalled product, description of the issue, and the potential adverse health ramifications that could occur. Instructions for return of product were enclosed in the mailing. Synthes will also provide additional notification and instruction to physicians and to patients (via their physicians).
Physicians with questions related to this medical device recall should contact Synthes at 1 (800) 620-7025, ext. 5375. Any adverse reactions/events experienced with use of the Synex II Central Body devices should be reported to Synthes at:
-Phone: 1 (800) 752-0128, or
-E-mail: ComplaintUnit@synthes.com
Patients with questions are encouraged to speak with their surgeon.
Adverse reactions or quality problems experienced with these products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax at:
-Online: http://www.fda.gov/medwatch/report.htm
-Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
-Fax: 1 (800) FDA-0178
Synthes: A leading medical device company
Synthes is a leading global medical device company. We develop, produce and market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.
For further information please contact
Gilgian Eisner, Investor Relations, Synthes, Inc.
Phone +41 32 720 4745, Fax +41 32 720 4811
Email: investor.relations@synthes.com
http://www.synthes.com
Restrictions Subject to US Securities Law
Synthes, Inc. management believes certain statements in this media release may constitute "Forward-Looking Statements" within the meaning of the "Private Securities Litigation Reform Act of 1995". These statements include but are not limited to those with respect to the potential for Synthes to offer new products and market existing ones, as well as the expected sales and sales growth of Synthes. These statements are made on the basis of management's views and assumptions regarding future events and business performance as of the time the statements are made. Actual results may differ materially from those expressed or implied. Such differences may result from the ability of Synthes to successfully develop and introduce new products and services and market existing products and services in a competitive marketplace and changes in the economic conditions that may affect the performance of the operations of Synthes.
In addition, changes in competitive conditions and regulatory developments may affect future business performance, and changing market conditions may affect the valuation of Synthes securities. In addition, it should be noted that past financial and operational performance of the company is not necessarily indicative of future financial and operational performance. Synthes undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
The securities of Synthes have been offered and sold outside the United States and have not been and will not be registered under the U.S. Securities Act of 1933, as amended ("Securities Act"). Such securities may not be offered, sold or transferred in the U.S. or to U.S. Persons (as defined in the regulations of the Securities Act), except pursuant to a registration statement filed under the Securities Act or under an applicable exemption under the Securities Act. Hedging transactions involving such securities may not be conducted unless in compliance with the Securities Act. The Synthes securities are deemed "Restricted Securities" as that term is defined in Rule 144 under the Securities Act.
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