FDA says recalled Synthes devices are health hazard

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FDA says recalled Synthes devices are health hazard
Wed Nov 4, 2009 1:12pm EST


ZURICH (Reuters) - The U.S. Food and Drug Administration has classified a recall of Synthes' Synex II Central Body components as Class I, meaning the products could pose an imminent health hazard.

Swiss medical device company Synthes voluntarily recalled all Synex II Central Body components on September 14 following six adverse event reports.

"Synthes advises that surgeons and hospitals in possession of the subject devices must stop implanting them immediately," the company said in a statement.

The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium.

(Writing by Lisa Jucca; Editing by Jon Loades-Carter)

[Harrison]

* Synex II Central Body components classified as Class I
* Company recalled devices globally on Sept. 14
* Company says implants must stop immediately


ZURICH, Nov 5 (Reuters) - The U.S. Food and Drug Administration has classified a recall of Synthes' (SYST.VX) Synex II Central Body components as Class I, meaning the products could pose an imminent health hazard.

Swiss medical device company Synthes voluntarily recalled all Synthex II Central Body components on Sept. 14 following six adverse event reports.

"Synthes advises that surgeons and hospitals in possession of the subject devices must stop implanting them immediately," the company said in a statement.

The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium. (Writing by Lisa Jucca; Editing by Jon Loades-Carter)

http://www.reuters.com/article/rbssH...65698020091104

[Harrison]

Synthes recalling spinal implant


Medical device maker Synthes Inc., of West Chester, said today that it is recalling some spinal implants that could collapse.

The U.S. Food and Drug Administration has classified the recall of vertebral implants called Synthes Synex II Central Body components as "class I," meaning the products could pose an imminent hazard to health in patients, Synthes said.

Synthes initiated a voluntary recall on Sept. 14, the company said. It said it took action after receiving six reports of patients suffering moderate to severe symptoms six to 15 months after implantation. Potential adverse health issues could include neural injury, increased pain, and a need for additional surgery, the company said.

According to Bloomberg News, Gilgian Eisner, spokesman for Synthes' Zurich-based parent company, said Synthes is trying to determine what is causing the collapse in a small number of patients. An older generation of the devices can still be safely used, he said.

Doctors should step monitoring of patients with the implants, Synthes said.

- Reid Kanaley

[Harrison]

FDA Classifies Synthes' Voluntary Medical Device Recall of Synex II Central Body Components as a Class I Recall


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