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FDA classifies Synthes’ voluntary recall of spine implant as Class I

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Synthes announced this week 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 Sept. 14, 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 6 to 15 months post-implantation, according to a Synthes press release.

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, according to the release.

Synthes recommends that surgeons and hospitals in possession of the subject devices must stop implanting them immediately. Physicians should contact Synthes for return instructions.

The company also recommends that physicians conduct annual monitoring of patients via radiographs and pain assessment measures.

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, according to the company press release.

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).

In the press release, company officials said Synthes notified hospitals and sales consultants of this recall through mail. The notification included identification of the recalled product, a 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), according to the release.

For more information:

• 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 1-800-752-0128, or by e-mail at ComplaintUnit@synthes.com. Patients with questions are encouraged to speak with their surgeon.
• www.fda.gov/medwatch/report.htm or www.fda.gov/MedWatch/getforms.htm.