Medical Devices
Synthes USA, Ti Synex II Vertebral Body Replacement (VBR)
| Recall Class: | Class I | ||||
| Date Recall Initiated: | September 14, 2009 | ||||
| Product: | Ti Synex II Vertebral Body Replacement (VBR)
This recall involves part numbers 04.808.001-11, Synex II Central Body, Titanium (all lots).
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| Use: | This device is a vertebral body replacement device that is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma (that is, a fracture). | ||||
| Recalling Firm: | Synthes USA 1302 Wrights Lane East West Chester, Pennsylvania 19380-3417 | ||||
| Reason for Recall: | Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device. | ||||
| Public Contact: | Physicians who have:
Patients who have this recalled device and have increased pain, other symptoms, or questions should contact their surgeon. For more information, see Useful Links below.
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| FDA District: | Philadelphia | ||||
| FDA Comments: | Hospitals and surgeons that have these recalled devices must stop implanting them immediately. On September 23, 2009, the company notified hospitals and sales consultants about this recall by mail. The company:
On November 09, 2009, the company sent physicians a follow up letter for their patients. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Useful Links:
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