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STRYKER RECALLS A SPINAL IMPLANT DEVICE

Stryker Recalls a Spinal Implant Device

The FDA recently announced a recall initiated by Stryker that affects all lots of OASYS Midline Occiput Plate distributed between April 23, 2010 and February 12, 2013. The Plate is used during spinal implant surgery and helps stabilize the junction between the occipital bone (the bone at the back of the skull through which the spinal cord passes) and the vertebrae in the cervical spine. The recall was prompted by cases of post-operative fracture affecting the Plate that could result in serious adverse effects, "including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant." Due to the potential for such grave health consequences, the device recall was "Class I" - the most serious type of recall. Stryker recommends urgent evaluation of patients "experiencing symptoms including pain, weakness, or numbness."

Source: FDA, http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm366713.htm

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