| Subject: | Class I Recall of Synthes USA, Ti Synex II Vertebral Body Replacement |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 13 Nov 2009 - 10:00 am |
| Audience: Orthopedic and neurological healthcare professionals, hospital risk managers The Food and Drug Administration (FDA) is notifying healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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